Mechanical Ventilation Clinical Trial
Official title:
Hemodynamic Effects of Ketamine Compared With Propofol as Continuous ICU Sedation in Mechanically Ventilated Patients
Verified date | January 2024 |
Source | Menoufia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Menoufia University | Shibin Al Kawm | Menoufia |
Lead Sponsor | Collaborator |
---|---|
Menoufia University |
Egypt,
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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