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

NCT06368219 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 0108161
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Keywords

midazolam; propofol; ketamine; procedural sedation

Outcome Measures

Primary Outcomes (1)

• Induction and recovery time for both combinations

  the induction and recovery time of ketamine/midazolam versus ketamine/propofol combinations used for procedural sedation in an Emergency setting.

  2 hours

Secondary Outcomes (1)

• incidence and severity of adverse events

  2 hours

Study Arms (2)

midazolam- ketamine combination

ACTIVE COMPARATOR

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

Drug: ketamine- midazolam versus ketamine- propofol

propofol- ketamine combination

ACTIVE COMPARATOR

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

Drug: ketamine- midazolam versus ketamine- propofol

Interventions

ketamine- midazolam versus ketamine- propofol 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)

midazolam- ketamine combination; propofol- ketamine combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Central Study Contacts

Asmaa Ramadan

CONTACT

01274627276; a_ramadan15@alexmed.edu.eg

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 16, 2024
• Study Start: April 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share