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Ketamine Versus Propofol as ICU Sedation

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06243822
Enrollment
100
Registered
2024-02-06
Start date
2022-10-01
Completion date
2023-12-01
Last updated
2024-02-06

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

Conditions

Ketamine, Mechanical Ventilation, Propofol, Sedation

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.

Interventions

DRUGKetamine

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.

DRUGPropofol

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.

Sponsors

Menoufia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
heart rateevery 15 min for the first hour then every hour for next six hours then every six hours for 48 hoursmeasure heart rate
mean arterial blood pressureevery 15 min for the first hour then every hour for next six hours then every six hours for 48 hoursmeasure mean arterial blodd pressure

Countries

Egypt

Outcome results

None listed

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