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
• Status: Not yet recruiting
• Phase: Early Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Emergencies
• Procedural Sedation

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