NCT06368219

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Procedural Sedation

Interventions

Type	Name	Description
DRUG	ketamine- midazolam versus ketamine- propofol	* 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)

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-09-01
• Completion: 2024-10-01
• First posted: 2024-04-16
• Last updated: 2024-04-16