[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"opioid-induced-respiratory-depression\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:opioid-induced-respiratory-depression":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,55,90],{"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":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100637012","pupillometry-in-identifying-risk-of-postoperative-opioid-induced-respiratory-depression-in-children-undergoing-tonsillectomy-100637012",false,"NCT07573150","Pupillometry in Identifying Risk of Postoperative Opioid-induced Respiratory Depression in Children Undergoing Tonsillectomy","Pupillometry in Identifying Postoperative Opioid-induced Respiratory Depression in Children Undergoing Tonsillectomy","Inclusion Criteria:\n\n* Age 3 to less than 18 years\n* Scheduled to undergo tonsillectomy with or without adenoidectomy\n* Planned postoperative recovery in a monitored clinical setting (e.g., post-anesthesia care unit)\n* Ability to obtain informed consent from parent or legal guardian and assent from the participant when developmentally appropriate\n\nExclusion Criteria:\n\n* Known neurologic or ophthalmologic conditions that may affect pupillary function\n* Use of medications known to significantly alter pupillary response outside of standard perioperative care\n* Inability to obtain adequate pupillometry measurements (e.g., due to eye injury or inability to safely perform measurement)\n* Patients not receiving opioids as part of perioperative care\n* Any condition that, in the opinion of the investigator, would interfere with study participation or data interpretation",true,"ALL","3 Years","17 Years",{"count":21,"type":22},300,"ESTIMATED","OBSERVATIONAL","This study will evaluate whether quantitative pupillometry measurements can be used to identify children at risk for postoperative opioid-induced respiratory depression (OIRD) following tonsillectomy. Opioid-induced respiratory depression is a serious and potentially life-threatening complication that can occur after surgery, and current monitoring approaches are limited in their ability to predict which patients are at highest risk.\n\nIn this prospective observational cohort study, approximately 300 pediatric patients undergoing tonsillectomy will undergo non-invasive pupillometry measurements at defined perioperative time points, including preoperative, intraoperative, and postoperative periods. Pupillometry measurements will be collected using a commercially available, FDA-regulated infrared pupillometer. These measurements will include pupil size, constriction and dilation velocities, and latency in response to light stimulation.\n\nPupillometry data will be collected for research purposes only and will not be used to guide clinical care or treatment decisions. Standard clinical care will not be altered as part of this study. Clinical outcomes, including the occurrence of postoperative opioid-induced respiratory depression, opioid use, sedation levels, pain scores, and other postoperative events, will be recorded from the medical record.\n\nThe goal of this study is to evaluate the relationship between pupillary response patterns and the occurrence of postoperative respiratory depression, and to support the development of predictive models that may improve early identification of patients at risk for opioid-related adverse events.",[26,27,28],"Opioid-Induced Respiratory Depression","Postoperative Complications (Cardiopulmonary)","Respiratory Complications Due to Anesthesia",[30,31,32,33,34,35,36,37,38,39,40,26,41],"Sedation","Postoperative Period","Perioperative Monitoring","Pediatrics","Pupillary Light Reflex","Pupillometry","Analgesia","Anesthesia","Opioids","Hypoventilation","Oxygen Desaturation","Respiratory Depression","RECRUITING","2026-05-06",{"date":45,"type":46},"2026-05-08","ACTUAL",{"date":48,"type":46},"2026-05-04",{"date":50,"type":22},"2027-04-30",{"name":52,"class":53},"NeurOptics Inc","INDUSTRY",2,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":16,"sex":17,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":66,"studyType":23,"phases":4,"briefSummary":67,"conditions":68,"keywords":72,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":89},"100610423","timing-of-opioid-administration-and-postoperative-respiratory-depression-100610423","NCT07227389","Timing of Opioid Administration and Postoperative Respiratory Depression.","The Relationship Between Timing of Opioid Administration and Postoperative Respiratory Depression.","Inclusion Criteria:\n\n* Written informed consent\n* Adults ≥18 years of age and ≤85 years of age\n* Patients planned for general anesthesia with an expected anesthetic time of at least 2 hours\n* Patients expected to receive postoperative opioid analgesia\n\nExclusion Criteria:\n\n* Non-operative procedure (imaging)\n* Patients not admitted to the PACU postoperatively\n* Use of patient-controlled analgesia systems\n* Female patients who are pregnant or breastfeeding\n* Patients with asymmetric lung disease\n* American Society of Anesthesiologists (ASA) classification V\n* Emergency surgery (ASA E Modifier)","18 Years","85 Years",{"count":65,"type":22},52,"1 Day","The goal of this study is to determine if a relationship can be detected between the administration of an opioid and quantitative respiratory depression in spontaneously breathing non-intubated patients who have undergone general anesthesia and have received perioperative opioids.\n\nThe primary aim is to determine the temporal effect of opioid administration on respiratory depression as assessed by minute ventilation with a reduction of at least 20% in the percent of predicted minute ventilation.\n\nA secondary aim is to determine a dose response of opioid administration and its effect on minute ventilation.\n\nThe investigators aim to determine the influence of opioid administration on minute ventilation on spontaneously breathing patients during post-anesthesia care unit (PACU) stay.",[69,70,71],"Respiratory Complications","Opioid Induced Respiratory Depression","Postoperative Respiratory Complications",[73,74,75,76,77],"opioids","bio-impedance","hypoxia","hypercapnia","minute ventilation","NOT_YET_RECRUITING","2025-11-13",{"date":81,"type":46},"2025-11-14",{"date":83,"type":22},"2025-12",{"date":85,"type":22},"2029-01-01",{"name":87,"class":88},"Wayne State University","OTHER",1,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":16,"sex":17,"minAge":62,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":89},"100465278","phase-1-reversal-of-opioid-induced-respiratory-depression-with-opioid-antagonists-100465278","NCT05338632","Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists","Reversal of Opioid-induced Respiratory Depression With Opioid Antagonists - a Study in Opioid naïve Individuals and Chronic Opioid Users Under Real-life Conditions","ROAR","Inclusion Criteria:\n\nHealthy volunteers\n\n1. Signed the informed consent form (ICF) and able to comply with the study requirements and restrictions listed therein;\n2. Male and female subjects, age 18 to 70 years, inclusive;\n3. 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 serum pregnancy test prior to enrolment and must agree to use a medically acceptable means of contraception from screening through at least 1 month after the last dose of study drug;\n4. Body Mass Index (BMI) 18 to 30 kg\u002Fm2, inclusive;\n5. Healthy as defined by the Investigator, based on a medical evaluation that includes the subject's medical and surgical history, physical examination, vital signs, lab chemistry: estimated glomerular filtration rate \\>60 mL\u002Fmin as estimated by the CKD-EPI equation, and AST or ALT levels \\\u003C 3.0 times the upper limit of normal at screening, and negative serology tests for HIV, acute hepatitis B, or acute hepatitis C;\n6. No history of substance use disorder;\n\nChronic opioid users\n\n1. Signed the consent form and able to comply with the requirements and restrictions listed therein;\n2. Males or females age 18 to 70 years, inclusive;\n3. 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 serum pregnancy test prior to enrolment and must agree to use a medically acceptable means of contraception from screening through at least 1 3 month after the last dose of study drug.\n4. BMI 18 to 32 kg\u002Fm2, inclusive;\n5. Opioid tolerant patients administered prescription opioids at daily doses ≥ 60 mg oral morphine equivalents (See Table 3);\n6. Stable as defined by the Investigator, based on a medical evaluation that includes the subject's medical and surgical history, physical examination, vital signs, 12-lead ECG, hematology, and blood chemistry;\n\nExclusion Criteria:\n\nHealthy volunteers\n\n1. Currently meet the criteria for diagnosis of substance use disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria on any substance;\n2. Any other active medical condition, organ disease or concurrent medication or treatment that may either compromise subject safety or interfere with study endpoints;\n3. Consume, on average, \\>27 20 units\u002Fweek of alcohol in men and \\> 20 13 units\u002Fweek of alcohol in women (1 unit = 1 glass (250 mL) beer, 125 mL glass of wine or 25 mL of 40% spirit);\n4. Previous or current treatment with opioid agonist, partial agonist, or antagonist treatment within 30 days prior to the first study drug administration;\n5. Significant traumatic injury, major surgery, or open biopsy within the prior 4 weeks of informed consent;\n6. History of suicidal ideation within 30 days prior to informed consent or history of a suicide attempt in the 6 months prior to informed consent;\n7. Measured systolic blood pressure greater than 160 or less than 95 mmHg or diastolic pressure greater than 95 mmHg at screening;\n8. History or presence of allergic response to fentanyl, sufentanil or naloxone;\n9. 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;\n10. Treatment with another investigational drug within 3 months prior to dosing or having participated in more than 4 investigational drug studies within 1 year prior to screening;\n11. Site staff or subjects affiliated with, or a family member of, site staff directly involved in the study;\n\nChronic opioid users\n\n1. Currently meet the criteria for diagnosis of moderate or severe substance use disorder according to the DSM-5 criteria on any substances other than opioids, caffeine, or nicotine;\n2. Any active medical condition, organ disease or concurrent medication or treatment that may either compromise subject safety or interfere with study endpoints;\n3. Consume, on average, \\>27 units\u002Fweek of alcohol in men and \\>20 units\u002Fweek of alcohol in women (1 unit = 1 glass (250 mL) beer, 125 mL glass of wine or 25 mL of 40% spirit);\n4. Currently receiving medication-assisted treatment for the treatment of opioid-use disorder;\n5. Significant traumatic injury, major surgery, or open biopsy within the prior 4 weeks of informed consent;\n6. History of suicidal ideation within 30 days prior to informed consent or history of a suicide attempt in the 6 months prior to informed consent;\n7. Measured systolic blood pressure greater than 160 or less than 95 mmHg or diastolic pressure greater than 95 mmHg at screening;\n8. History or presence of allergic response to study medication;\n9. Opioid tolerant patients 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.\n10. Estimated glomerular filtration rate \\\u003C60 mL\u002Fmin as estimated by the CKD-EPI equation;\n11. Anemia at screening or donation of \\> 250 mL of blood or plasma within the last 3 months;\n12. Positive serology tests for HIV, acute hepatitis B, or acute hepatitis C (OT patients with asymptomatic hepatitis B or C infection may be enrolled);\n13. AST or ALT levels \\>3.0 times the upper limit of normal at screening;\n14. Treatment with another investigational drug within 3 months prior to dosing or having participated in more than 4 investigational drug studies within 1 year prior to screening;\n15. Site staff or subjects affiliated with, or a family member of, site staff directly involved in the study.","70 Years",{"count":100,"type":22},24,"INTERVENTIONAL",[103],"PHASE1","n this pharmacokinetic\u002Fpharmacodynamic modelling study we will determine the ability of intranasal and intravenous naloxone and intravenous nalmefene to reverse opioid (fentanyl and sufentanil)- induced respiratory depression in healthy volunteers and chronic opioid users to develop dosing recommendations in case of opioid-induced respiratory depression from an opioid overdose in clinical practice and in the out-of-hospital overdose.",[70,106],"Chronic Opioid Use",[108,109],"Reversal of opioid induced respiratory depression","Intranasal naloxone","2025-01-29",{"date":112,"type":46},"2025-01-31",{"date":114,"type":46},"2022-06-24",{"date":116,"type":22},"2026-10-01",{"name":118,"class":88},"Leiden University Medical Center"]