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NCT06368219 Clinical Trial

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

Procedural Sedation Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06368219
Other study ID # 0108161
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date April 2024
Est. completion date October 2024

Study information
Verified date March 2024
Source Alexandria University
Contact Asmaa Ramadan
Phone 01274627276
Email a_ramadan15@alexmed.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date October 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Alexandria University

Outcome
Type Measure Description Time frame Safety issue
Primary 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 incidence and severity of adverse events 7) Incidence of complications between the two groups using World Society of Intravenous Anesthesia (SIVA) international sedation task force to standardize reporting adverse events 2 hours
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