drugset / Trial / NCT06185127

Dexmedetomidine-ketamine Combination Versus Fentanyl-midazolam During Bronchoscopy

NCT06185127

Phase 3 Completed 50 enrolled University of Patras
RandomizedParallel-groupDouble-blindTreatment

Summary

Sedation during flexible bronchoscopy (FB) should maintain an adequate respiratory drive, ensure maximum comfort for the patient, and warrant that the objectives of the procedure are achieved. Nevertheless, the optimal sedation method for FB has yet to be established. This study aimed to compare the standard recommended combination of midazolam-fentanyl (MF) with that of dexmedetomidine-ketamine (DK) for patient sedation during FB. Patients subjected to FB were randomly assigned to a DK (n=25) and an MF group (n=25). The primary outcome was the rate of critical desaturation events (arterial oxygen saturation \<80% with nasal oxygen supply 2 L/min). Secondary outcomes included sedation depth, hemodynamic complications, adverse events, and patient and bronchoscopist satisfaction.

Timeline

Start
2019-09-01
Primary completion
2020-05-31
Completion
2020-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 0.5 ug/kg
Comparator Fentanyl Other / unclassified 50 ug
Subject Ketamine Small molecule 50 mg
Comparator Midazolam Small molecule 1 mg
Comparator Midazolam Small molecule 2 mg

Indications