[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"respiratory-depression\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:respiratory-depression":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,42,64,101,128,150,180],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100590426","phase-1-ena-001-for-opioid-induced-respiratory-depression-100590426",false,"NCT06967259","ENA-001 for Opioid Induced Respiratory Depression","A Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ENA-001 Administered as Intravenous (IV) and Intramuscular (IM) Doses","Inclusion Criteria:\n\n1. Subjects must be willing to give written informed consent for the trial and able to adhere to dose and visit schedules.\n2. Male and female, \\>18 to ≤55 years of age.\n3. Subject must weigh ≥50 to ≤100 kg.\n4. Subjects must have Body Mass Index \\[weight\u002Fheight2 (kg\u002Fm2)\\] between 18 to 30 kg\u002Fm2 (inclusive).\n5. Have no clinical or electrocardiographic signs of ischemic heart disease as determined by the Investigator with normal cardiac intervals appropriate for their gender. The Screening 12 lead electrocardiogram (ECG) conduction intervals must be within gender specific normal range (e.g., QTcf female \\\u003C 450 msec QT corrected for heart rate by Fridericia's cube root formula (QTcF) males \\\u003C 430 msec, PR interval ≤ 220 msec). ECGs are to be judged by the investigator or sub-investigator as per standardized procedures.\n6. Subjects' clinical laboratory tests (blood hematology, blood chemistry, coagulation and urinalysis and liver enzymes must be in normal range. Where applicable, normal range is defined as in the FDA guidance Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials.\n7. Vital sign measurements must be within the following ranges during screening and on Day -1:\n\n   1. body temperature, \\>35.5 C to ≤37.5 C\n   2. systolic blood pressure, \\>90 to ≤140 mmHg\n   3. diastolic blood pressure, \\>40 to ≤95 mmHg\n   4. pulse rate, \\>55 to ≤100 bpm\n8. Non-vasectomized men must agree to use a condom with spermicide (when marketed in the country), double-barrier contraception, abstain from heterosexual intercourse, or have a sole sexual partner of non-childbearing potential during the trial and for 3 months after stopping the medication. Male subjects must agree not to donate sperm from the time of dosing until 90 days after dosing.\n9. Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent) must have a negative pregnancy test prior to enrollment as well as prior to each subsequent period of dosing administration, and must agree to at least one of the following contraception requirements from screening through at least 3 months after the last dose of study drug:\n\n   1. Be sexually inactive (abstinent)\n   2. Hormonal or non-hormonal intrauterine device in place for at least 3 months prior to dosing with a barrier method (condom or diaphragm) and spermicide at least 3 months after last dose of study drug.\n   3. Double barrier methods (e.g., condom and diaphragm) with spermicide for at least 30 days prior to screening and through at least 3 months after last dose of study drug. Hormonal oral contraception + use of condoms and spermicides is an acceptable double barrier method.\n   4. Surgical sterilization of the partner (vasectomy at least six months prior to dosing) with a barrier method (e.g., condom or diaphragm) and spermicide through at least 3 months after last dose of study drug.\n   5. Female subjects who claim to be sexually inactive but become sexually active during the course of the study must agree to use a double barrier method (e.g., condom and diaphragm) with spermicide from the time of the start of sexual activity through at least 3 months after last dose of study drug.\n\n      In addition, female subjects of childbearing potential must be advised to remain sexually inactive or to keep the same birth control method through at least 3 months after last dose of study drug.\n\n      Females of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to dosing:\n      * Hysteroscopic sterilization and using a barrier method (e.g., condom or diaphragm) and spermicide throughout the study.\n      * Bilateral tubal ligation or bilateral salpingectomy and be using a barrier method (e.g., condom or diaphragm) and spermicide throughout the study.\n      * Hysterectomy.\n      * Bilateral oophorectomy.\n   6. Women with amenorrhea for at least 1 year prior to dosing and who have follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status, are considered post-menopausal and therefore of non childbearing potential.\n10. Subjects must demonstrate a normal Allen's test for both hands, to assure adequate arterial collateral circulation.\n11. Subjects must be free of any clinically significant disease that would interfere with the study evaluations.\n\nExclusion Criteria:\n\n1. Current diagnosis of psychiatric disease requiring daily medication, including controlled or uncontrolled schizophrenia and current or recently treated depressive disorders.\n2. Current diagnosis of Generalized Anxiety Disorder (DSM-5) requiring treatment.\n3. History of alcohol abuse (more than an average of two (2) drinks per day) within the past two (2) years.\n4. History of drug abuse within the past two years.\n5. History of regular smoking\u002Fvaping or any use of nicotine products within the past year (\\>5 per week means exclusion).\n6. Failure to take or test positive of the drug of abuse tests or alcohol urine test at screening or check-in.\n7. Positive for HIV, or Hepatitis B or C at screening.\n8. Blood donation or blood loss within 60 days of screening or plasma donation within 7 days of screening.\n9. Subjects with a history of bleeding disorders or coagulopathies.\n10. History of dyspnea, asthma, tuberculosis, chronic obstructive pulmonary disease, sleep apnea or any other ventilatory \u002F lung disease.\n11. Treatment with another investigational drug within 3 months prior to screening or having participated in more than four investigational drug studies within 1 year prior to screening.\n12. History of moderate to severe motion sickness.\n13. Subjects who are unwilling to remove excessive facial hair preventing sealing of the occlusive face mask.\n14. Subjects who, in the opinion of the investigator, will not be able to participate optimally in the study.\n15. Any surgical or medical condition which might significantly alter the distribution, metabolism or excretion of any drug. The investigator should be guided by evidence of any of the following, and be discussed with the Sponsor prior to enrollment into the trial:\n\n    1. history of pancreatic injury or pancreatitis;\n    2. history or presence of liver disease or liver injury;\n    3. history of previously elevated ALT\u002FAST values;\n    4. history or presence of impaired renal function as indicated by clinically significant elevation in creatinine, BUN\u002Furea, urinary albumin, or clinically significant urinary cellular constituents; or\n    5. history of urinary obstruction or difficulty in voiding.\n16. Subject who has a history of any infectious disease within 4 weeks prior to drug administration that in the opinion of the investigator, affects the subject's ability to participate in the trial.\n17. Subjects who are part of the study staff personnel or family members of the study staff personnel.\n18. Subjects who have demonstrated allergic reactions (e.g., food, drug, atopic reactions, or asthmatic episodes) which, in the opinion of the investigator and Sponsor, interfere with their ability to participate in the trial.\n19. Subjects who have a history of malignancy and are in remission \\\u003C5 years.\n20. Personal or family history of malignant hyperthermia.\n21. Personal or family history of arrhythmias or ECG conductance abnormalities.\n22. Subjects with an average daily consumption of a large quantity of coffee, tea, (\\> 6 cups per day), energy drinks, or equivalent.\n23. Subjects with a known history of allergy to lidocaine, xylocaine, or other local anesthetic agents.\n24. Subjects with any history of radial-artery (in either arm) disease or injury, or prior known difficulty with placement of arterial line cannula.\n25. Subjects with history of known difficult airway access and presence of a \"nonreassuring\" airway exam (as determined by the investigator), gastroesophageal reflux disease, gastric motility disorders, or delayed gastric emptying.\n26. Use of any prescription or over-the-counter medications (such as antacids, vitamins, minerals, dietary\u002Fherbal preparations, St. John's Wort, and nutritional supplements) within 14 days prior to Screening; and use of CYP450 inhibitors\u002Finducers within 30 days prior to Screening.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},36,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study is a Phase I clinical trial to assess the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) profiles with single intravenous (IV) and intramuscular (IM) doses of ENA-001.",[28],"Respiratory Depression","RECRUITING","2026-05-07",{"date":32,"type":33},"2026-05-08","ACTUAL",{"date":35,"type":33},"2025-05-14",{"date":37,"type":22},"2026-12-30",{"name":39,"class":40},"Enalare Therapeutics Inc.","INDUSTRY",3,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":4},"100526660","phase-2-ena-001-for-post-operative-respiratory-depression-pord-100526660","NCT06137638","ENA-001 for Post Operative Respiratory Depression (PORD)","A Placebo-controlled, Double-blind, Randomized Trial to Evaluate the Efficacy of ENA-001 in Preventing Postoperative Respiratory Depression","Inclusion Criteria:\n\n1. Willing to give written informed consent for the trial and willing\u002Fable to adhere to study procedures.\n2. Scheduled to undergo a major elective surgery, including abdominal, laparoscopic, nephrology, thoracic (non-cardiac), orthopedic (e.g., shoulder and ankle surgery), where the subject will be transferred to recover in the general postanesthesia recover unit (PACU) and extubation will be performed in the operating room or PACU.\n3. Undergoing surgical procedure with a intraoperative requirement of ≥ 250 µg of fentanyl; Enrolled base on expected pain management to necessitate ≥ 250 µg of fentanyl intraoperatively.\n4. Male and female, ≥18 years of age.\n5. American Society of Anesthesiologists (ASA) physical status classification 1-3.\n6. Have no clinical or electrocardiographic signs of ischemic heart disease as determined by the Investigator. The Screening 12 lead ECG conduction intervals must be within gender specific normal range (e.g., QTcF female \\< 450 msec QTcF males \\< 430 msec, PR interval ≤ 220 msec). ECGs are to be judged by the investigator or sub-investigator as per standardized procedures.\n7. Clinical laboratory tests (blood hematology, blood chemistry, coagulation and urinalysis) must not include any significant clinical abnormalities.\n8. Vital sign measurements must be within the following ranges during screening and on the day of dosing:\n\n   1. body temperature, ≥35.5°C to ≤37.5°C\n   2. systolic blood pressure, ≥90 to ≤150 mm Hg\n   3. diastolic blood pressure, ≥50 to ≤95 mm Hg\n   4. pulse rate, ≥40 to ≤100 bpm\n9. Non-vasectomized men must agree to use a condom with spermicide, double-barrier contraception, abstain from heterosexual intercourse, or have a sole-sexual partner of non childbearing potential during the trial and for 3 months after stopping the medication. Male subjects must agree not to donate sperm from the time of dosing until 90 days after dosing.\n10. Women of childbearing potential (defined as all women who are not surgically sterile or postmenopausal for at least 1 year prior to informed consent) must have a negative pregnancy test prior to enrolment and must agree to the following contraception requirements from screening through 3 months after dosing of the study drug:\n\n    1. Be sexually inactive (abstinent)\n    2. Intrauterine device in place for at least three months prior to dosing with a barrier method (condom or diaphragm) and spermicide throughout the study.\n    3. Double barrier methods (e.g., condom and diaphragm) with spermicide for at least 14 days prior to dosing and throughout the study.\n    4. Surgical sterilization of the partner (vasectomy at least six months prior to dosing) with a barrier method (e.g., condom or diaphragm) and spermicide throughout the study.\n    5. Female subjects who claim to be sexually inactive but become sexually active during the course of the study must agree to use a double barrier method (e.g., condom and diaphragm) with spermicide from the time of the start of sexual activity through completion of the study. In addition, female subjects of childbearing potential must be advised to remain sexually inactive or to keep the same birth control method for at least 14 days following study medication administration. Females of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to dosing:\n\n    \u003C!-- -->\n\n    1. Hysteroscopic sterilization and be using a barrier method (e.g., condom or diaphragm) and spermicide throughout the study.\n    2. Bilateral tubal ligation or bilateral salpingectomy and be using a barrier method (e.g., condom or diaphragm) and spermicide throughout the study.\n    3. Hysterectomy.\n    4. Bilateral oophorectomy. Women with amenorrhea for at least 1 year prior to dosing and who have follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status, are considered post menopausal and therefore of non-childbearing potential.\n11. Subjects must be free of any clinically significant disease that would interfere with the study evaluations.\n\nExclusion Criteria:\n\n1. Ongoing treatment for a pre-existing chronic pain condition\n2. Use of an epidural \u002F spinal block \u002F major nerve block for the surgical procedure\n3. Surgical procedure that may interfere with the collection of data under the study protocol, such as craniofacial surgery which may impact the placement of a face mask for pulmonary function measurements.\n4. Current diagnosis of psychiatric disease, including anxiety disorder, that is uncontrolled and\u002For restricting normal daily function.\n5. History of alcohol abuse (more than an average of 2-drinks per day) within the past 2 years.\n6. History of drug abuse within the past 2 years.\n7. History of regular smoking within the past year (\\>5 per week means exclusion).\n8. Positive for HIV, or Hepatitis B or C at screening.\n9. Blood donation or blood loss within 60 days of screening or plasma donation within 7 days of screening.\n10. Current or recent presentation of clinically significant of dyspnea, asthma, tuberculosis, chronic obstructive pulmonary disease, sleep apnea (central or obstructive) or any other ventilatory \u002F lung disease.\n11. Treatment with another investigational drug within 3 months prior to screening or having participated in more than four investigational drug studies within 1 year prior to screening.\n12. History of moderate to severe motion sickness.\n13. Subjects who are unwilling to remove excessive facial hair preventing sealing of the occlusive face mask.\n14. Subjects who, in the opinion of the investigator, will not be able to participate optimally in the study.\n15. Any surgical or medical condition which might significantly alter the distribution, metabolism or excretion of any drug. The investigator should be guided by evidence of any of the following, and be discussed with the sponsor prior to enrollment into the trial:\n\n    1. history of pancreatic injury or pancreatitis;\n    2. history or presence of liver disease or liver injury;\n    3. history or presence of impaired renal function as indicated by clinically significant elevation in creatinine, BUN\u002Furea, urinary albumin, or clinically significant urinary cellular constituents; or\n    4. history of urinary obstruction or difficulty in voiding.\n16. Subject who has a history of any infectious disease within 4 weeks prior to drug administration that in the opinion of the investigator, affects the subject's ability to participate in the trial.\n17. Subjects who are part of the study staff personnel or family members of the study staff personnel.\n18. Subjects who have demonstrated allergic reactions (e.g., food, drug, atopic reactions or asthmatic episodes) which, in the opinion of the investigator and sponsor, interfere with their ability to participate in the trial.\n19. Subjects who have a history of malignancy and are in remission \\<5 years.\n20. Personal or family history of malignant hyperthermia.\n21. History of arrhythmias or ECG conductance abnormalities.\n22. Subjects with history of known difficult airway access and presence of a \"non-reassuring\" airway exam (as determined by the investigator), gastroesophageal reflex disease, gastric motility disorders, or delayed gastric emptying, or any condition that may lead to delayed gastric emptying such as diabetes.",{"count":50,"type":22},200,[52],"PHASE2","This study is a Phase II, randomized, placebo-controlled, double-blind trial in 200 subjects having general anesthesia for major elective surgery with postoperative pain management to evaluate the efficacy, safety and tolerability of ENA-001 as a therapy to prevent post operative respiratory depression.",[28],"NOT_YET_RECRUITING","2026-02-25",{"date":58,"type":33},"2026-02-27",{"date":60,"type":22},"2026-12-15",{"date":62,"type":22},"2027-07-15",{"name":39,"class":40},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":17,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":23,"phases":76,"briefSummary":78,"conditions":79,"keywords":84,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":100},"100575859","phase-4-comparison-of-remimazolam-and-propofol-in-endoscopic-examinations-and-treatments-100575859","NCT06777758","Comparison of Remimazolam and Propofol in Endoscopic Examinations and Treatments","The Comparison of Remimazolam or Propofol Used Alone Versus in Combination for Moderate Sedation During Endoscopic Examination and Treatment.","Remimazolam","Inclusion Criteria:\n\n* Subjects are between 20-80 years old.\n* Anesthesiologists rated ASA as between I and III.\n* Patients undergoing upper gastrointestinal endoscopic examination or therapy.\n\nExclusion Criteria:\n\n* Allergy to Propofol, Remimazolam, or opioid medications.\n* Emergency surgery.\n* Pregnancy.\n* History of malignant hyperthermia.\n* Impaired liver or kidney function.\n* Airway difficulties due to pharyngeal tumors.\n* Refusal to participate.","20 Years","80 Years",{"count":75,"type":22},90,[77],"PHASE4","This study aims to evaluate the efficacy and safety of Remimazolam, either used alone or in combination with Propofol, for moderate sedation anesthesia during endoscopic therapies or examinations. Additionally, it seeks to explore whether their combination can further enhance the quality of patient anesthesia and recovery outcomes.",[80,28,81,82,83],"Postoperative Complications","Postoperative Nausea","Vomiting","Constipation",[85,86,87,88,89],"endoscope","Respiratory depression","Remimazolam、","Sedation","BYFAVO","2025-05-06",{"date":92,"type":33},"2025-05-08",{"date":94,"type":33},"2025-02-12",{"date":96,"type":22},"2026-12-31",{"name":98,"class":99},"Kaohsiung Veterans General Hospital.","OTHER",1,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":23,"phases":111,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":127},"100575490","effect-of-percutaneous-electrical-acupoint-stimulation-on-the-improvement-of-incidence-of-adverse-respiratory-events-100575490","NCT06772961","Effect of Percutaneous Electrical Acupoint Stimulation on the Improvement of Incidence of Adverse Respiratory Events","Effect of Percutaneous Electrical Acupoint Stimulation on the Improvement of Incidence of Adverse Respiratory Events in the Emergence Period From General Anesthesia After Tracheal Extubation: A Single-center Randomized Controlled Study","Inclusion Criteria:\n\n* 1: Age \\>18 years old.\n\n  2: ASA I-III\n\n  3: Patients undergoing elective general anesthesia surgery who are extubated upon arrival to the PACU\n\nExclusion Criteria:\n\n* 1: Preoperative comorbidities include severe cardiovascular or respiratory diseases\n\n  2: Serious reflux aspiration during the perioperative period\n\n  3: Concurrent psychiatric disorders\n\n  4: Local skin infections or nerve damage at the upper limb Taiyuan and Hegu acupoints","100 Years",{"count":110,"type":22},236,[112],"NA","The goal of this study is to investigate the effect of combined acupoint electrical stimulation at Taiyuan (LU9) and Hegu (LI4) on improving the incidence of respiratory adverse events after extubation in patients during the recovery period from general anesthesia.\n\nThe main content of this study involves selecting patients who have undergone general anesthesia and are admitted to the Post Anesthesia Care Unit (PACU), with an expected 236 participants. The researchers will randomly assign participants to either the TEAS group or the control group using a random number table. In the TEAS group, electrodes will be applied to the upper limbs at the Taiyuan and Hegu acupoints, without intravenous infusion, and connected to a stimulation device. The stimulation will use a frequency of 2\u002F100 Hz with sparse-dense waves, and the intensity will be adjusted to the maximum current that the patient can tolerate, starting at the time of extubation and continuing for 30 minutes. The control group will receive routine care. Throughout the process, no invasive procedures will be performed.\n\nIn the PACU, the participants will:\n\nBe positioned in a 30° head-up tilt position, with continuous ECG monitoring. The SpO2 alarm on the monitor will be set to 95%.\n\nThe same anesthesiologist will perform extubation according to the extubation criteria.\n\nAfter extubation, participants will receive routine oxygen therapy via a nasal cannula at 3L\u002Fmin with a CO2 end-expiratory monitoring module attached to the other end of the cannula. Simultaneously, the TEAS group will undergo transcutaneous electrical stimulation for 30 minutes, or the control group will receive routine care.\n\nParticipants will be observed in the PACU for at least 30 minutes. If no adverse events occur and the Steward score is ≥4, the patient will be deemed ready for discharge and escorted back to the ward. If there is any significant change in the patient's condition, they will be transferred to the ICU .\n\nIf any respiratory-related adverse events occur, measures such as awakening the patient, supporting the jaw, increasing oxygen flow, or administering mask oxygen will be taken to ensure patient safety, and these events will be recorded in the \"PACU Postoperative General Anesthesia Patient Condition Observation and Nursing Record.\"",[115,28,116,117],"Extubation","Acupuncture Points","Hypoxia","2025-02-06",{"date":120,"type":33},"2025-02-10",{"date":122,"type":33},"2025-01-25",{"date":124,"type":22},"2025-12-25",{"name":126,"class":99},"Nanjing First Hospital, Nanjing Medical University",2,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":16,"sex":17,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":139,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":100},"100578813","phase-4-effect-of-propofol-versus-remimazolam-intravenous-anesthesia-on-respiratory-depression-100578813","NCT06816173","Effect of Propofol Versus Remimazolam Intravenous Anesthesia on Respiratory Depression","Effect of Propofol Versus Remimazolam Intravenous Anesthesia Combined With Regional or Caudal Block on Respiratory Depression in Young Children: A Randomized Controlled Clinical Study","Inclusion Criteria:\n\n1. Aged 3-6 years, gender unrestricted;\n2. American Society of Anesthesiologists (ASA) physical status classification of I-II;\n3. Body Mass Index (BMI) between 14 kg\u002Fm² and 25 kg\u002Fm²;\n4. Patients requiring elective surgery that can be completely anesthetized through regional or caudal block;\n5. The child's parent or legal guardian voluntarily participates in this trial and signs the informed consent form.\n\nExclusion Criteria:\n\n1. Children requiring special care or under the supervision of a court or social welfare agency;\n2. Children who have received general anesthesia within 3 months prior to the screening period;\n3. Children with a history of respiratory diseases within the past 2 weeks or those deemed to have difficult airway management: Modified Mallampati score of III or IV;\n4. Children with severe cardiovascular diseases or endocrine system abnormalities;\n5. Children with known psychiatric disorders or cognitive impairments;\n6. Children with abnormal liver function, ALT (alanine aminotransferase) and\u002For AST (aspartate aminotransferase) \\>1.5 times the upper limit of normal; children with total bilirubin exceeding the upper limit of normal; children with abnormal kidney function, creatinine and\u002For blood urea nitrogen higher than the upper limit of normal;\n7. Children known or suspected to be allergic to the study drug or benzodiazepines.","3 Years","6 Years",{"count":138,"type":22},96,[77],"General anesthesia is the preferred choice for pediatric patients, but the induction of volatile anesthetics via face mask may cause preoperative anxiety and postoperative delirium. Total intravenous anesthesia (TIVA) is more suitable for pediatric patients, as it can effectively alleviate preoperative anxiety, reduce the risk of postoperative delirium and mania, shorten hospital stay, reduce medical burden, and increase parental satisfaction. Propofol, although effective for anesthesia, has drawbacks such as injection pain and respiratory and circulatory suppression. Remimazolam is a novel ultra-short-acting benzodiazepine drug, which has no injection pain, minimal impact on respiration and circulation, and rapid onset and elimination, making it suitable for children. However, research on remimazolam in children is limited. This study aims to compare the effect of propofol and remimazolam intravenous anesthesia combined with regional or caudal block on respiratory depression in preschoolers.",[28],"2025-02-04",{"date":120,"type":33},{"date":145,"type":22},"2025-02",{"date":147,"type":22},"2026-02",{"name":149,"class":99},"Second Affiliated Hospital of Wenzhou Medical University",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":23,"phases":160,"briefSummary":161,"conditions":162,"keywords":166,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":127},"100544876","closed-loop-o2-use-during-high-flow-oxygen-treatment-of-critical-care-adult-patients-cloudhfot-100544876","NCT06374589","Closed-Loop O2 Use During High Flow Oxygen Treatment of Critical Care Adult Patients (CLOUDHFOT)","Closed-Loop O2 Use During High Flow Oxygen Treatment of Critical Care Adult Patients (CLOUDHFOT)- a Randomized Cross-over Study","CLOUDHFOT","Inclusion Criteria:\n\n* Patient admitted to the ER\n* Requiring NHFO\n* Requiring FiO2 ≥ 30% to keep SpO2 in the target ranges defined by the clinician\n* Aged over 18 years\n* Written informed consent signed and dated by the patient or one relative in case that the patient is unable to consent, after full explanation of the study by the investigator and prior to study participation\n* In case that the consent is given by the relative, patient consent will be requested as soon as the patient will be able to provide informed written consent\n\nExclusion Criteria:\n\nPatients who fulfil any of the following exclusion criteria are not eligible for study participation:\n\n* Patient with indication for immediate CPAP, NIV, or invasive mechanical ventilation\n* Hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine \\> 1 mg\u002Fh\n* Low quality on the SpO2 measurement using finger and ear sensor (quality index below 60% on the Massimo SpO2 sensor, which is displayed by a red or orange color bar)\n* Severe acidosis (pH ≤ 7.30)\n* Pregnant woman\n* Patients deemed at high risk for need of mechanical ventilation within the next 12 hours\n* Chronic or acute dyshemoglobinemia: methemoglobin, CO poisoning, sickle cell disease\n* Tracheotomized patient\n* Formalized ethical decision to withhold or withdraw life support\n* Patient under guardianship\n* Patient deprived of liberties\n* Patient included in another interventional research study under consent\n* Patient already enrolled in the present study in a previous episode of acute respiratory failure\n\nPost enrollment exclusion criteria\n\n* Apparition of a persistent low quality SpO2 signal\n* Need for an emergent intubation\n* Discharge from ER",{"count":159,"type":22},50,[112],"High flow nasal oxygen therapy (HFNO) is an established modality in the supportive treatment of patients suffering from acute hypoxemic respiratory failure. The high humidified gas flow supports patient's work of breathing, reduces dead space ventilation, and improves functional residual capacity while using an unobtrusive patient's face interface \\[Mauri et al, 2017; Möller et al, 2017\\].\n\nAs hyperoxia is considered not desirable \\[Barbateskovic et al, 2019\\] during any oxygen therapy, the inspired O2 concentration is usually adapted to a pre-set SpO2 target-range of 92-96% in patients without hypercapnia risk, and of 88-92% if a risk of hypercapnia is present \\[O'Driscoll et al, 2017; Beasley et al, 2015\\]. In most institutions, the standard of care is to manually adapt the FiO2, although patients frequently have a SpO2 value outside the target range.\n\nA new closed loop oxygen controller designed for HFNO was recently developed (Hamilton Medical, Bonaduz, Switzerland). The clinician sets SpO2 targets, and the software option adjusts FiO2 to keep SpO2 within the target ranges. The software option offers some alarms on low and high SpO2 and high FiO2. Given the capability, on the one hand, to quickly increase FiO2 in patients developing sudden and profound hypoxia, and, on the other hand, of automatically preventing hyperoxia in patients improving their oxygenation, such a system could be particularly useful in patients treated with HFNO.\n\nA short-term (4 hours vs 4 hours) crossover study indicated that this technique improves the time spent within SpO2 pre-defined target for ICU patients receiving high-flow nasal oxygen therapy \\[Roca et al, 2022\\]. Due to its simplicity, HFNO is increasingly used outside the ICU during transport and in the Emergency Room (ER). This environment poses specific challenges, as patients may deteriorate very quickly and depending on patient's flow, healthcare providers can easily be overwhelmed. We thus propose to evaluate closed loop controlled HFNO in ER patients.\n\nThe hypothesis of the study is that closed loop oxygen control increases the time spent within clinically targeted SpO2 ranges and decreases the time spent outside clinical target SpO2 ranges as compared to manual oxygen control in ER patients treated with HFNO.",[163,164,28,165],"Acute Hypoxemic Respiratory Failure","Acute Hypercapnic Respiratory Failure","Respiratory Failure",[167,168,169],"Acute respiratory failure (ARF)","HFNC","Closed-loop","2025-01-27",{"date":172,"type":33},"2025-01-28",{"date":174,"type":33},"2024-03-21",{"date":176,"type":22},"2026-05-30",{"name":178,"class":179},"Başakşehir Çam & Sakura City Hospital","OTHER_GOV",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":187,"enrollmentInfo":188,"targetDuration":4,"studyType":190,"phases":4,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":4},"100553854","hemidiaphragmatic-paralysis-following-supraclavicular-brachial-plexus-blockade-100553854","NCT06491498","Hemidiaphragmatic Paralysis Following Supraclavicular Brachial Plexus Blockade.","Hemidiaphragmatic Paralysis Following Ultrasound-Guided Supraclavicular Brachial Plexus Blockade in Patients Undergoing Upper Limb Surgery","Inclusion Criteria:\n\n* Age between 18 and 60 years. American Society of Anesthesiologists physical status 1 to 3, Able to give informed consent. Body mass index (BMI) less than 35.\n\nExclusion Criteria:\n\n* Patient refusal. Known\u002Fsuspected allergy to local anesthetics Pregnancy Body mass index (BMI) greater than 35 kg\u002Fm2 Neuromuscular disease Obstructive or restrictive pulmonary disease Known or suspected PNP or diaphragmatic dysfunction Other medical or anatomic contraindication to brachial plexus blockade as judged by the investigator\n\n  * local infection.\n  * significant coagulation abnormalities.","60 Years",{"count":189,"type":22},60,"OBSERVATIONAL","The supraclavicular block is a regional anesthetic technique used as an alternative or adjunct to general anesthesia or used for postoperative pain control for upper extremity surgeries (mid-humerus through the hand). First introduced in 1911 by Kulenkampff as a landmark-based approach, the associated risk of pneumothorax was likely responsible for the technique falling out of favor. With the advent of ultrasonography, La Grange described the utilization of the Doppler probe to identify arteries in 1978. Contemporarily, Kapral and colleagues advocated for the dynamic use of ultrasound to guide needle advancement in the supraclavicular position. Colloquially known as the \"spinal of the arm,\" the supraclavicular block is advantageous as the brachial plexus nerves are tightly packed in this approach and speed of onset is often rapidly achieved. However, because of this consolidated relationship, consider restricting volumes of local anesthesia to as low as possible to achieve goals, as compression ischemia may occur.",[28],"2024-07-08",{"date":195,"type":33},"2024-07-09",{"date":197,"type":22},"2024-07-01",{"date":199,"type":22},"2025-02-01",{"name":201,"class":99},"Sohag University"]