Status:
NOT_YET_RECRUITING
Safety and Efficacy of Dexmedetomidate vs. Midazolam for Procedural Sedation During Medical Thoracoscopy
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Medical Thoracoscopy
Eligibility:
All Genders
12-90 years
Phase:
PHASE3
Brief 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...
Detailed Description
Francis Richard Cruise was probably the first person to ever implement the idea of peeking into the pleural cavity with an endoscope, which he did back in 1865-1866 for examining an 11-year-old girl w...
Eligibility Criteria
Inclusion
- Age≥18 and ≤80 years
- Medical thoracoscopy performed for the work-up of undiagnosed pleural effusion
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT07184801
Start Date
October 1 2025
End Date
December 31 2026
Last Update
September 22 2025
Active Locations (1)
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1
Bronchoscopy suite
Chandigarh, Chandigarh, India, 160012