Safety and Efficacy of Dexmedetomidate vs. Midazolam for Procedural Sedation During Medical Thoracoscopy
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Medical Thoracoscopy
In brief
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.
Key facts
- Study ID
- NCT07184801
- Run by
- Post Graduate Institute of Medical Education and Research, Chandigarh
- People needed
- 56
- Starts
- 2025-10-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-03-18
Who can join
Age: 12 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age≥18 and ≤80 years
- Medical thoracoscopy performed for the work-up of undiagnosed pleural effusion
You may not qualify if…
- Patients with ICD in situ for more than 5 days
- SP02<92%
- Haemodynamic instability (systolic blood pressure ≤90 mmHg or >180mmHg, or diastolic BP >110mmHg) before the procedure
- MI/unstable angina in the last 3 months
- Hb<8g/dL, platelet<50000 cells/dL
- Lack of pleural space due to adhesion
- Uncorrected coagulopathy (PT>3 secs above control; APTT>10 secs above control
- Failure to provide informed consent
- Patients with known allergy or previously recorded severe adverse events to the sedatives used in the study
- Patients who required any anaesthetic/analgesic agent in past 7 days
- Patients on psychotropic drugs that may alter sensorium
Where it is running
- Bronchoscopy suite — Chandigarh, Chandigarh, India (enrolling)
Full record on ClinicalTrials.gov
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