drugset / Trial / NCT06368219

Propofol or Benzodiazepine Combined With Ketamine for Procedural Sedation in Emergency Setting

NCT06368219

Phase 0 Unknown 50 enrolled Alexandria University
RandomizedParallel-groupSingle-blindTreatment

Summary

This single blinded parallel randomized clinical trial will be conducted on 50 patients presented to Emergency Department of Alexandria Main University Hospital who are indicated for procedural sedation. All patients included in the study will be allocated randomly using computer software with concealment of randomization in to two groups: * Group A: 25 patients will receive ketamine (0.5 mg/kg) plus midazolam (0.05 mg/kg) * Group B: 25 patients will receive ketamine (0.5 mg/kg) plus propofol (0.5 mg/kg) Additional ketamine (0.25 mg/kg) will be administered in case of inadequate sedation in both groups. the two groups will be compared as regard incidence of complications World Society of Intravenous Anesthesia (SIVA) international sedation task force to standardize reporting adverse events

Timeline

Start
2024-04
Primary completion
2024-09
Completion
2024-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Midazolam Small molecule 0.05 mg/kg
Comparator Propofol Small molecule 0.5 mg/kg
Comparator Ketamine Small molecule 0.5 mg/kg

Indications

No indication recorded.