Ketamine Versus Propofol as ICU Sedation

Mechanical Ventilation Clinical Trial

Official title:

Hemodynamic Effects of Ketamine Compared With Propofol as Continuous ICU Sedation in Mechanically Ventilated Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06243822
• Other study ID #: 1/2023ANET9
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2024
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ketamine
• Mechanical Ventilation
• Propofol
• Sedation

Intervention

Drug:
• Ketamine
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.
• Propofol
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.

Locations

Country	Name	City	State
Egypt	Menoufia University	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	heart rate	measure heart rate	every 15 min for the first hour then every hour for next six hours then every six hours for 48 hours
Primary	mean arterial blood pressure	measure mean arterial blodd pressure	every 15 min for the first hour then every hour for next six hours then every six hours for 48 hours