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Completed

NCT Number: NCT06243822

Ketamine Versus Propofol as ICU Sedation

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.

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Key information

Conditions

Ketamine Mechanical Ventilation Propofol Sedation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Menoufia University

Shibīn al Kawm, Menoufia, 32511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ketamine

Drug

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

Drug

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.

Primary outcomes

  1. heart rate

    Time frame: every 15 min for the first hour then every hour for next six hours then every six hours for 48 hours

    measure heart rate

  2. mean arterial blood pressure

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 6, 2024
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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