A Randomized Controlled Trial for Studying the Efficacy and Safety of Dexmedetomidine Vs Midazolam for Procedural Sedation During Medical Thoracoscopy
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 90
Healthy Volunteers: f
View:
• Age≥18 and ≤80 years
• Medical thoracoscopy performed for the work-up of undiagnosed pleural effusion
Locations
Other Locations
India
Bronchoscopy suite
RECRUITING
Chandigarh
Contact Information
Primary
Inderpaul S Sehgal, DM
inderpgi@outlook.com
+91-1722756820
Time Frame
Start Date:2025-10-01
Estimated Completion Date:2026-12-31
Participants
Target number of participants:56
Treatments
Experimental: Group 1
Immediately before procedure~* 2 mL normal saline bolus~* 1 µg /Kg fentanyl in 0.9% normal saline (10 mL dose volume) IV as slow bolus~* Dexmedetomidine 1 µg /Kg in 0.9% normal saline (100 mL) over 10 minutes~During entire procedure~• Dexmedetomidine (30 mcg in 0.9% saline, 50 ml) infused at a rate of 0.5 µg /Kg/hour~Rescue boluses~* 0.5 µg /Kg of Fentanyl IV boluses up to 100 µg total.~* If further need of analgesia despite 100 µg of Fentanyl, Injection Tramadol 50 mg IV bolus as needed upto 200 mg total dose.
Active_comparator: Group 2
Immediately before procedure~* 2 mg midazolam~* 1 µg /Kg Fentanyl, in 0.9% saline IV slow bolus~* 100 mL 0.9% normal saline (100 mL) over 10 minutes During entire procedure~* 0.9% normal saline 50 mL infused at a rate of 0.5 µg /Kg/Hr Rescue boluses~* 0.5 µg /Kg of Fentanyl IV boluses up to 100 µg total.~* If further need of analgesia despite 100 µg of Fentanyl, Injection Tramadol 50 mg IV bolus as needed upto 200 mg total dose.