drugset / Trial / NCT05643066

Esketamine-propofol Versus Propofol for Flexible Bronchoscopy

NCT05643066 ↗

Phase 4 Completed 246 enrolled Fujian Provincial Hospital
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Bronchoscopy is a promising technology for lung and bronchus disease detection and therapy. However, this procedure is associated with a relatively high risk of hypoxemia, coughing, wheezing, and dyspnea. Despite the fact that propofol is the most commonly used agent in procedure sedation, the narrow therapeutic index remains challenging. Esketamine is the s-enantiomer of ketamine with potent analgesic and sedative properties. This study aims to test the hypothesis that adding subanesthetic esketamine to propofol is non-inferior to propofol alone for bronchoscopy on the recovery profile and discharge from the hospital.

Timeline

Start
2022-12-07
Primary completion
2023-12-18
Completion
2023-12-21

Outcome

Met primary endpoint

paper Both esketamine doses were non-inferior to propofol alone for discharge readiness: PMID 42369372 ↗

paper the risk difference was -3.0 percentage points (95% CI, -13.8 to 7.8; P non-inferiority = 0.003) at 0.1 mg/kg PMID 42369372 ↗

paper -5.1 percentage points (95% CI, -16.2 to 6.1; P non-inferiority = 0.012) at 0.2 mg/kg. PMID 42369372 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Esketamine Other / unclassified 0.1 mg/kg Intravenous
Subject Esketamine Other / unclassified 0.2 mg/kg Intravenous
Subject Propofol Small molecule 0.5 mg/kg Intravenous

Indications

No indication recorded.