Safety and Efficacy of Dexmedetomidate vs. Midazolam for Procedural Sedation During Medical Thoracoscopy
Recruiting
Phase 3
Interventional Study
Medical Thoracoscopy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 12 – 90
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 56 (estimated)
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh · Other
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About This Trial
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 thoracos…
Trial Locations
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Eligibility 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…
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