[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"drug-safety\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:drug-safety":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100560157","phase-4-efficacy-and-safety-of-fospropofol-in-adult-laparoscopic-surgery-a-clinical-trial-100560157",false,"NCT06573489","Efficacy and Safety of Fospropofol in Adult Laparoscopic Surgery: A Clinical Trial","Minimum Effective Dose and Maintenance Effectiveness of Fospropofol for General Anesthesia Induction in Adult Laparoscopic Abdominal Surgery: A Randomized, Single-Blind, Clinical Study","Inclusion Criteria:\n\n1. Adult age (18-65 years old)\n2. ASA（American Society of Anesthesiologists）grade I\\~II\n3. The estimated operation time is more than 3h, and laparoscopic abdominal surgery under general anesthesia is planned\n4. BMI value 18-30kg \u002Fm2\n5. Voluntary signing of informed consent\n\nExclusion Criteria:\n\n1. Those who have contraindications to general anesthesia or have a history of anesthesia accidents;\n2. Patients with craniocerebral loss, intracranial hypertension, stroke, unstable angina pectoris, myocardial infarction;\n3. Respiratory insufficiency, obstructive pulmonary disease, presence of a difficult airway, or determination of tracheal intubation difficulty (modified Markov score level III or IV)\n4. uncontrolled diabetes or high blood pressure;\n5. A history of drug use, alcoholism or drug dependence;\n6. Abuse or long-term use of narcotic, sedative and analgesic drugs;\n7. Those who are known or suspected to be allergic to or contraindicated by the process administration of various components or protocols of the study drug (sufentanil citrate injection, propofol medium\u002Flong chain fat milk, remifentanil hydrochloride for injection, and propofol disodium for injection);\n8. People with a history of mental illness;\n9. Participants in any drug clinical trial within 1 month before screening;\n10. Pregnant and lactating women; The reluctance of fertile women or men to use contraception throughout the trial; Subjects (including male subjects) who plan to become pregnant within 3 months after the trial;\n11. Subjects who have any other factors deemed unsuitable by the investigator for participation in this study.","ALL","18 Years","65 Years",{"count":20,"type":21},373,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This protocol is a clinical study of fospropofol disodium for general anesthesia in adults undergoing laparoscope-assisted abdominal surgery. The study has three main objectives: First, to explore the use of propofol disodium as the lowest effective dose for induction of general anesthesia; Secondly, to evaluate the efficacy and safety of fospropofol disodium in the maintenance phase of general anesthesia, and to determine its effective dose range; Finally, the effects of fospropofol disodium on Bispectral Index during induction, maintenance and recovery were studied, and compared with propofol to understand its characteristic changes. The randomized, single-blind, controlled design of the study, with an expected enrollment of 373 patients, was designed to achieve its objectives through a three-phase trial design to provide important clinical information about the safety and efficacy of the use of propofol disodium.",[27],"Drug Safety",[29,30],"Fospropofol","Efficacy and Safety","RECRUITING","2025-04-13",{"date":34,"type":35},"2025-04-16","ACTUAL",{"date":37,"type":35},"2024-09-15",{"date":39,"type":21},"2026-07-01",{"name":41,"class":42},"Hui Xu","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":43},"100584441","phase-1-use-of-intranasal-midazolam-to-reduce-stress-and-procedural-pain-in-premature-infants-during-routine-rop-examination-100584441","NCT06889376","Use of Intranasal Midazolam to Reduce Stress and Procedural Pain in Premature Infants During Routine ROP Examination.","The Use of Intranasal Sedation With Midazolam to Reduce Stress, Discomfort and Procedural Pain in Preterm Newborns and Infants During Routine ROP Screening","Inclusion Criteria:\n\n* Newborns qualified for ophthalmologic screening examination to detect retinopathy of prematurity (ROP):\n\n  a. Newborns\u002Finfants born before the 32 weeks of gestation and\u002For with a birth weight \\\u003C1500 g.\n* Obtaining informed consent from a parent\u002Flegal guardian.\n\nExclusion Criteria:\n\n* Newborns\u002Finfants not qualified for screening ophthalmologic examination (ROP).\n* Newborns\u002Finfants clinically unstable, with respiratory disorders\u002Fcardiovascular instability before the ophthalmologic examination.\n* Newborns\u002Finfants with congenital developmental defects.\n* Newborns\u002Finfants receiving analgesic\u002Fsedative medications for other reasons.","30 Weeks",{"count":53,"type":21},40,[55],"PHASE1","The goal of this study is to learn about the safety and effectiveness of intranasal midazolam in newborns and infants born prematurely, undergoing Retinopathy of Prematurity (ROP) screening.\n\nThe main question it aims to answer is:\n\n• Does use of intranasal midazolam is a safe, quick, non-invasive medication, that reduces the pain, stress, discomfort, and other complications in patients undergoing ROP screening?\n\nResearchers will compare the intervention group with a comparison group of the patients who will receive routine comfort care.",[27],[59,60,61],"intranasal midazolam","ROP screening","Premature infants","NOT_YET_RECRUITING","2025-03-16",{"date":65,"type":35},"2025-03-21",{"date":67,"type":21},"2025-03-24",{"date":69,"type":21},"2025-07-06",{"name":71,"class":42},"Polish Mother Memorial Hospital Research Institute"]