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

Early Phase 1

Not yet recruiting

• Conditions: Procedural Sedation
• Interventions: Drug: ketamine- midazolam versus ketamine- propofol

• Registration Number: NCT06368219
• Lead Sponsor: Alexandria University

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-29
• Study Start: 2024-04
• Study First Submitted QC: 2024-04-15
• Last Update Submitted: 2024-04-15
• Study First Posted: 2024-04-16
• Last Update Posted: 2024-04-16
• Primary Completion: 2024-09
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Adult patients (≥18 years) requiring procedural sedation and analgesia for painful procedures in ED . The following procedures are indications for PSA:
• Cardioversion
• Reduction of fracture or joint dislocation
• Procedures as central venous catheter (CVC) and chest tube insertion or wound management

Exclusion Criteria

• Patients with anticipated difficult airway.
• Post cardiac arrest patients.
• Contraindication to study drugs.
• Pregnant women.
• Patients > 65 years.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propofol- ketamine combination	ketamine- midazolam versus ketamine- propofol	- Group B: 25 patients will receive ketamine (0.5 mg/kg) plus propofol (0.5 mg/kg)(
midazolam- ketamine combination	ketamine- midazolam versus ketamine- propofol	- Group A: 25 patients will receive ketamine (0.5 mg/kg) plus midazolam (0.05 mg/kg

Primary Outcome Measures

Name	Time	Method
Induction and recovery time for both combinations	2 hours	the induction and recovery time of ketamine/midazolam versus ketamine/propofol combinations used for procedural sedation in an Emergency setting.

Secondary Outcome Measures

Name	Time	Method
incidence and severity of adverse events	2 hours	7) Incidence of complications between the two groups using World Society of Intravenous Anesthesia (SIVA) international sedation task force to standardize reporting adverse events