Safety and Efficacy of Dexmedetomidate vs. Midazolam for Procedural Sedation During Medical Thoracoscopy

NCT07184801 · tracked via the Priya Life Science India tracker

Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Phase

Phase 3

Started

2025-10-01

Last updated

2026-03-18

Condition(s) studied

Medical Thoracoscopy

Investigational drug(s) / intervention(s)

DexmedetomidineMidazolam

Dexmedetomidine: The patient will receive dexmedetomidine bolus dose of 1 µg /Kg over 10 minutes followed by 0.5 µg /kg/hr 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

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 /Kg/Hr as placebo.

Study 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

Sex

ALL

Min age

12 Years

Max age

90 Years

Healthy volunteers

Inclusion Criteria: 1. Age≥18 and ≤80 years 2. Medical thoracoscopy performed for the work-up of undiagnosed pleural effusion Exclusion Criteria: 1. Patients with ICD in situ for more than 5 days 2. SP02\<92% 3. Haemodynamic instability (systolic blood pressure ≤90 mmHg or \>180mmHg, or diastolic BP \>110mmHg) before the procedure 4. MI/unstable angina in the last 3 months 5. Hb\<8g/dL, platelet\<50000 cells/dL 6. Lack of pleural space due to adhesion 7. Uncorrected coagulopathy (PT\>3 secs above control; APTT\>10 secs above control 8. Failure to provide informed consent 9. Patients with known allergy or previously recorded severe adverse events to the sedatives used in the study 10. Patients who required any anaesthetic/analgesic agent in past 7 days 11. Patients on psychotropic drugs that may alter sensorium

Primary outcome measure(s)

Total amount of rescue medication (sedation or analgesia) required during MT. — 6 hours
The total amount of rescue medication bolus will be counted

Trial sites (1)

Facility	City	Region	Status
Bronchoscopy suite	Chandigarh	Chandigarh	Recruiting