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

RecruitingPhase 3Ages 12 Years - 90 YearsAllPost Graduate Institute of Medical Education and …
NCT07184801 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Dexmedetomidine
  • Midazolam
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Where

1 site
Bronchoscopy suite
Chandigarh, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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