Actively Recruiting
Safety and Efficacy of Dexmedetomidate vs. Midazolam for Procedural Sedation During Medical Thoracoscopy
Led by Post Graduate Institute of Medical Education and Research, Chandigarh · Updated on 2026-03-18
56
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of Dexmedetomidate vs. Midazolam for Procedural Sedation During Medical Thoracoscopy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years
- Undergoing medical thoracoscopy for evaluation of undiagnosed pleural effusion
You will not qualify if you...
- Indwelling chest drain in place for more than 5 days
- Oxygen saturation below 92%
- Unstable blood pressure (systolic less than 90 mmHg or greater than 180 mmHg, or diastolic greater than 110 mmHg) before procedure
- Heart attack or unstable angina in the past 3 months
- Hemoglobin less than 8 g/dL or platelet count less than 50,000 cells/dL
- No pleural space due to adhesions
- Uncorrected blood clotting disorder (prolonged PT or APTT)
- Unable to provide informed consent
- Known allergy or severe reaction to study sedatives
- Use of anesthetic or pain medications in the past 7 days
- Use of psychotropic drugs that affect mental status
AI-Screening
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Trial Site Locations
Total: 1 location
1
Bronchoscopy suite
Chandigarh, Chandigarh, India, 160012
Actively Recruiting
Research Team
I
Inderpaul S Sehgal, DM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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