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

NCT ID: NCT06368219

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2024-10-31

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

Conditions

Procedural Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

midazolam- ketamine combination

\- Group A: 25 patients will receive ketamine (0.5 mg/kg) plus midazolam (0.05 mg/kg

Group Type: ACTIVE_COMPARATOR

ketamine- midazolam versus ketamine- propofol

Intervention Type: DRUG

• 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)

propofol- ketamine combination

\- Group B: 25 patients will receive ketamine (0.5 mg/kg) plus propofol (0.5 mg/kg)(

Group Type: ACTIVE_COMPARATOR

ketamine- midazolam versus ketamine- propofol

Intervention Type: DRUG

• 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)

Interventions

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)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Asmaa Ramadan

Role: CONTACT

a_ramadan15@alexmed.edu.eg

01274627276

Other Identifiers

0108161

Identifier Type: -

Identifier Source: org_study_id