Ketamine Versus Propofol as ICU Sedation

Phase 4

Completed

• Conditions: Propofol; Ketamine; Sedation; Mechanical Ventilation
• Interventions: Drug: Propofol; Drug: Ketamine

• Registration Number: NCT06243822
• Lead Sponsor: Menoufia University

Brief Summary

this study is to assess the hemodynamic profile of ketamine compared with propofol in critically ill, mechanically ventilated adult Patients study will be carried out on 100 mechanically ventilated patients who received one sedative agent propofol or ketamine The patients will be randomized into two equal groups to receive either ketamine or propofol Group 1 (Ketamine group): ketamine is initiated at 0.5 mg/kg/h and titrated by 0.25 mg/kg/h every 15 minutes to a maximum dosage of 4 mg/kg/h to achieve appropriate sedation. Group 2 (Propofol group): Propofol is initiated at 0.3 to 0.6 mg /kg/hr. and titrated by 0.3 to 0.6 mg/kg/h every 5 to 10 minutes up to a maximum dosage of 4.5 to 4.8 mg/kg/hr. to achieve appropriate sedation.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Primary Completion: 2023-10-01
• Study Completion: 2023-12-01
• Status Verified: 2024-01
• Study First Submitted: 2024-01-14
• Study First Submitted QC: 2024-01-28
• Last Update Submitted: 2024-01-28
• Study First Posted: 2024-02-06
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• mechanically ventilated, and receive sedation with continuous infusion propofol, or ketamine for at least 24 hours

Exclusion Criteria

• Receiving propofol or ketamine concurrently.

  • Transferred from an outside hospital on sedation.
  • Receiving ketamine for an indication other than sedation.
  • Daily intake of opioids.
  • Contraindication to any drug used in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propofol group	Propofol	-
Ketamine group	Ketamine	-

Primary Outcome Measures

Name	Time	Method
heart rate	every 15 min for the first hour then every hour for next six hours then every six hours for 48 hours	measure heart rate
mean arterial blood pressure	every 15 min for the first hour then every hour for next six hours then every six hours for 48 hours	measure mean arterial blodd pressure

Trial Locations

Locations (1)

Menoufia University; 🇪🇬 Shibīn Al Kawm, Menoufia, Egypt