MedTrace Logo

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

NCT07184801 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-03-18

No results posted yet for this 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.

Conditions

  • Medical Thoracoscopy

Interventions

DRUG

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

DRUG

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.

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Principal Investigators

  • Inderpaul S Sehgal, DM · PGIMER, Chandigarh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-10-31
Completion
2026-12-31

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07184801 on ClinicalTrials.gov