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

Alexandria University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Procedural Sedation

Treatments: Drug: ketamine- midazolam versus ketamine- propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT06368219

0108161

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

midazolam- ketamine combination

Active Comparator group

Description:

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

Treatment:

Drug: ketamine- midazolam versus ketamine- propofol

propofol- ketamine combination

Active Comparator group

Description:

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

Treatment:

Drug: ketamine- midazolam versus ketamine- propofol