drugset / Trial / NCT06181188

Use of Ketamine for Conscious Sedation in Flexible Bronchoscopy

NCT06181188 ↗

Phase 4 Completed 66 enrolled Brooke Army Medical Center
RandomizedParallel-groupSingle-blindDiagnostic

Summary

In this study, the investigators plan to conduct a single blinded randomized controlled trial in the Pulmonary Service to demonstrate the efficacy of ketamine and its utility in moderate sedation. Patients presenting for bronchoscopy who meet inclusion criteria will be approached, and if amenable, will be consented and enrolled. Patients will be randomized to receive either 1 mg of midazolam and ketamine 0.25 to 0.5 mg/kg loading dose with subsequent doses of 10-20 mg IV or standard fentanyl and midazolam in 25mcg and 1mg increments respectively for moderate sedation during their procedure. The primary outcome will be patient satisfaction, which will be measured a using patient clinical satisfaction form. A number of secondary outcomes will include the following: (1) provider satisfaction (2) the time from sedation administration to procedure start (when the scope is inserted), (3) the time from sedation to scope removal from the trachea (4) the time from sedation to discharge (defined as the time from the end of the procedure until the patient meets discharge criteria from the recovery area), (5) total dose of medications given (including midazolam, fentanyl, and ketamine), (6) adverse events, (7) vital signs, (8) and the need for additional medications, in particular reversal agents.

Timeline

Start
2019-07-15
Primary completion
2023-10-30
Completion
2023-10-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fentanyl Other / unclassified 25 ug —
Subject Ketamine Small molecule 10 mg Intravenous
Subject Ketamine Small molecule 20 mg Intravenous
Background Midazolam Small molecule 1 mg Intravenous

Indications

No indication recorded.