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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-90
SponsorPost Graduate Institute of Medical Education and Research, Chandigarh

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 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 criteria

Qualifiers

Age≥18 and ≤80 years

Medical thoracoscopy performed for the work-up of undiagnosed pleural effusion

Disqualifiers

Patients with ICD in situ for more than 5 days

SP02<92%

Haemodynamic instability (systolic blood pressure ≤90 mmHg or >180mmHg, or diastolic BP >110mmHg) before the procedure

MI/unstable angina in the last 3 months

Trial design

Treatments tested in this trial

  • Dexmedetomidine
  • Midazolam

Treatment groups

56 Participants
are divided into 2 treatment groups