Ketamine Versus Propofol as ICU Sedation

NCT06243822 | Completed Phase 4

• 1 other identifier: 1/2023ANET9
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Ketamine; Propofol; Sedation; Mechanical Ventilation

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Ketamine group

ACTIVE COMPARATOR

Drug: Ketamine

propofol group

ACTIVE COMPARATOR

Drug: Propofol

Interventions

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.

Ketamine group

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.

propofol group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mechanically ventilated, and receive sedation with continuous infusion propofol, or ketamine for at least 24 hours

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia University

Shibīn al Kawm, Menoufia, 32511, Egypt

Location

MeSH Terms

Interventions

Ketamine; Propofol

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic

Study Officials

• Mostafa Saieed Mansour, MD

  Menoufia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anaesthesiology

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: February 6, 2024
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-01

Locations

EG (1)