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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06243822
Other study ID # 1/2023ANET9
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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