[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607149":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":45,"responsibleParty":64,"collaborators":43,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":43,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":48,"whyStopped":43,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Post Graduate Institute of Medical Education and Research, Chandigarh","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1","EXPERIMENTAL","Immediately before procedure\n\n* 2 mL normal saline bolus\n* 1 µg \u002FKg fentanyl in 0.9% normal saline (10 mL dose volume) IV as slow bolus\n* Dexmedetomidine 1 µg \u002FKg in 0.9% normal saline (100 mL) over 10 minutes\n\nDuring entire procedure\n\n• Dexmedetomidine (30 mcg in 0.9% saline, 50 ml) infused at a rate of 0.5 µg \u002FKg\u002Fhour\n\nRescue boluses\n\n* 0.5 µg \u002FKg of Fentanyl IV boluses up to 100 µg total.\n* If further need of analgesia despite 100 µg of Fentanyl, Injection Tramadol 50 mg IV bolus as needed upto 200 mg total dose.",[13],"Drug: Dexmedetomidine",{"label":15,"type":16,"description":17,"interventionNames":18},"Group 2","ACTIVE_COMPARATOR","Immediately before procedure\n\n* 2 mg midazolam\n* 1 µg \u002FKg Fentanyl, in 0.9% saline IV slow bolus\n* 100 mL 0.9% normal saline (100 mL) over 10 minutes During entire procedure\n* 0.9% normal saline 50 mL infused at a rate of 0.5 µg \u002FKg\u002FHr Rescue boluses\n* 0.5 µg \u002FKg of Fentanyl IV boluses up to 100 µg total.\n* If further need of analgesia despite 100 µg of Fentanyl, Injection Tramadol 50 mg IV bolus as needed upto 200 mg total dose.",[19],"Drug: Midazolam",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Dexmedetomidine","The patient will receive dexmedetomidine bolus dose of 1 µg \u002FKg over 10 minutes followed by 0.5 µg \u002Fkg\u002Fhr infusion titrated to desired sedation level (RSS 3). For patients who do not achieve an RSS of 3, we will give 1 mg bolus of midazolam. All additional boluses will be recorded. The patient will initially receive a bolus of 2 mL 0.9% normal saline intravenously for blinding purpose",[9],[27],"Dexmed",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Midazolam","The patient will receive midazolam bolus dose of 2 mg IV. They will receive an infusion of normal saline over 10 minutes for blinding purpose. Further need of sedation (as assessed by RSS) will be met by additional IV boluses of 1 mg midazolam. During the procedure they will receive continuous infusion of normal saline at a rate of 0.5 µg \u002FKg\u002FHr as placebo.",[15],[33],"Midas",[35],{"name":36,"affiliation":37,"role":38},"Inderpaul S Sehgal, DM","PGIMER, Chandigarh","PRINCIPAL_INVESTIGATOR",[40],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","+91-1722756820",null,"inderpgi@outlook.com",[46],{"facility":47,"status":48,"city":49,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Bronchoscopy suite","RECRUITING","Chandigarh","160012","India","IN",{"type":54,"coordinates":55},"Point",[56,57],76.7884,30.73629,{"lat":57,"lon":56},[60],{"name":61,"role":41,"phone":62,"phoneExt":63,"email":44},"Inderpaul S Sehgal, MD,DM","+91-172275","6823",{"type":38,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Inderpaul singh","Associate Professor","100607149","phase-3-safety-and-efficacy-of-dexmedetomidate-vs-midazolam-for-procedural-sedation-during-medical-thoracoscopy-100607149",false,"NCT07184801","Safety and Efficacy of Dexmedetomidate vs. Midazolam for Procedural Sedation During Medical Thoracoscopy","A Randomized Controlled Trial for Studying the Efficacy and Safety of Dexmedetomidine Vs Midazolam for Procedural Sedation During Medical Thoracoscopy","DEMISE-MT","Inclusion Criteria:\n\n1. Age≥18 and ≤80 years\n2. Medical thoracoscopy performed for the work-up of undiagnosed pleural effusion\n\nExclusion Criteria:\n\n1. Patients with ICD in situ for more than 5 days\n2. SP02\\\u003C92%\n3. Haemodynamic instability (systolic blood pressure ≤90 mmHg or \\>180mmHg, or diastolic BP \\>110mmHg) before the procedure\n4. MI\u002Funstable angina in the last 3 months\n5. Hb\\\u003C8g\u002FdL, platelet\\\u003C50000 cells\u002FdL\n6. Lack of pleural space due to adhesion\n7. Uncorrected coagulopathy (PT\\>3 secs above control; APTT\\>10 secs above control\n8. Failure to provide informed consent\n9. Patients with known allergy or previously recorded severe adverse events to the sedatives used in the study\n10. Patients who required any anaesthetic\u002Fanalgesic agent in past 7 days\n11. Patients on psychotropic drugs that may alter sensorium","ALL","12 Years","90 Years",{"count":79,"type":80},56,"ESTIMATED","INTERVENTIONAL",[83],"PHASE3","Medical thoracoscopy can be performed under procedural sedation (conscious sedation) in most of the cases. Procedural sedation is a state where the patient lies comfortably without much movement, does not feel pain and has a dissociative state (separation of mind and body. In view of the existing literature, we hypothesize that use of dexmedetomidine for procedural sedation during medical thoracoscopy will improve the ease of performing the procedure, lower the consumption of rescue analgesics and risk of intra- and post-procedure complications, improve the yield, shorten the recovery period and reduce the post-procedure pain in comparison to midazolam. In this study we propose to show that procedural sedation with dexmedetomidine during medical thoracoscopy is more beneficial for both patient and the clinician in terms of yield and shorter procedure time in comparison with conventional midazolam-fentanyl combination.",[86],"Medical Thoracoscopy",[88],"Thoracoscopy, Midazolam, sedation","2026-03-17",{"date":91,"type":92},"2026-03-18","ACTUAL",{"date":94,"type":92},"2025-10-01",{"date":96,"type":80},"2026-12-31",{"name":5,"class":6},1]