Dexmedetomidine versus Midazolam for Sedation During Medical Thoracoscopy
Official title: A Randomized Controlled Trial for Studying the Efficacy and Safety of Dexmedetomidine Vs Midazolam for Procedural Sedation During Medical Thoracoscopy
Run by Post Graduate Institute of Medical Education and Research, Chandigarh · NCT07184801 · Data updated 2026-11-12
This tests whether dexmedetomidine provides better sedation than midazolam for adults undergoing medical thoracoscopy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 12 Years to 90 Years |
| Sex | All |
| Enrollment | 56 (estimated) |
| Sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh Academic / other |
| Locations | 1 site (Chandigarh, Chandigarh) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | October 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | March 18, 2026 |
| Trial ID | NCT07184801 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 scheduled for medical thoracoscopy to investigate undiagnosed pleural effusion who meet the trial's safety criteria (adequate oxygenation, stable haemodynamics, and acceptable coagulation) are ideal candidates.
✕Probably not a fit
Patients with significant respiratory or haemodynamic instability, uncorrected coagulopathy, prolonged indwelling chest drains, recent myocardial infarction, allergy to the study drugs, recent anesthetic/analgesic exposure, or those on psychotropic medications are unlikely to be eligible or to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 interventional trial compares dexmedetomidine with the conventional midazolam-fentanyl regimen for procedural sedation in adults having medical thoracoscopy. Outcomes include ease of performing the procedure, need for rescue analgesics, intra- and post-procedure complications, diagnostic yield, procedure duration, recovery time, and post-procedure pain. Eligible participants are adults (18–80 years) undergoing thoracoscopy for undiagnosed pleural effusion who meet prespecified safety and coagulation criteria; each participant will receive one of the two sedative regimens with standard peri-procedural monitoring. The trial is conducted at a single center with structured monitoring and recovery assessments to compare safety and efficacy measures.
Why it matters
Potential benefit: If successful, patients could have smoother procedures with less pain, fewer complications, shorter recovery, and potentially improved diagnostic yield.
How similar studies have gone: Dexmedetomidine has shown benefits over midazolam in other procedural sedation settings—such as less respiratory depression and faster recovery—but its use specifically for medical thoracoscopy is less well studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Bronchoscopy suite
Chandigarh, Chandigarh, India Recruiting
Study contacts
- Principal investigator: Inderpaul S Sehgal, DM — PGIMER, Chandigarh
- Study coordinator: Inderpaul S Sehgal, DM
- Email: inderpgi@outlook.com
- Phone: +91-1722756820
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.