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

Status

Not yet recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06368219

Enrollment

Registered

2024-04-16

Start date

2024-04-30

Completion date

2024-10-31

Last updated

2024-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Procedural Sedation

Keywords

midazolam, propofol, ketamine, procedural sedation

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

Interventions

DRUGketamine- 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Induction and recovery time for both combinations	2 hours	the induction and recovery time of ketamine/midazolam versus ketamine/propofol combinations used for procedural sedation in an Emergency setting.

Secondary

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

Contacts

Primary ContactAsmaa Ramadan

a_ramadan15@alexmed.edu.eg01274627276

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026