Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in Geriatric Patients Under Invasive Ventilation

May 28, 2026 updated by: Mujtaba Alqaisoum, Helwan University

The study is a prospective randomized controlled trial comparing the efficacy and safety of propofol-ketamine ("Ketofol") versus propofol monotherapy in geriatric ICU patients. Eligible participants are critically ill elderly patients with a history of cardiac disease who require endotracheal intubation and have not yet received sedation. The investigators focus on a specific population in which geriatric patients have different pharmacokinetics and pharmacodynamics and are more prone to side effects than other populations.

Primary outcome: Incidence of hemodynamic instability (defined as hypotension requiring vasopressors), measured by mean arterial pressure (MAP) at baseline, during intubation, and post-intubation at 1, 3, 5, 10, 20, 30, and 60 minutes, then hourly for 24 hours.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

41

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 4942340
        • Recruiting
        • Badr University hospital in Cairo
        • Contact:
        • Principal Investigator:
          • Mujtaba monir Alqaisoum, Bachelor
        • Principal Investigator:
          • Mahmoud ibrahim Mostafa, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 65 years
  • Admitted to ICU with a diagnosis of infection (sepsis, septic shock, or pneumonia)
  • Known history of cardiac disease (e.g., ischemic heart disease, heart failure, arrhythmias)
  • Requiring endotracheal intubation for airway protection or respiratory failure
  • Informed consent obtained from patient or legal representative
  • Patient NOT on sedation prior randomization.

Exclusion Criteria:

  • Known allergy or contraindication to propofol or ketamine
  • Severe hepatic or renal dysfunction (Child-Pugh C, eGFR < 30 mL/min/1.73m²)
  • Uncontrolled hypertension (SBP > 180 mmHg or DBP > 110 mmHg)
  • Intracranial pathology (e.g., raised intracranial pressure, recent stroke, brain tumor)
  • Ongoing use of other sedative or anesthetic agents within 12 hours prior to intubation
  • Do-not-intubate or do-not-resuscitate orders
  • Participation in another interventional trial within the last 30 days
  • History of Psychosis
  • Severe Organ Dysfunction: Patients with Child-Pugh C hepatic failure
  • • Severe hypotension despite vasopressor therapy (systolic blood pressure < 100 mmHg or diastolic blood pressure < 70 mmHg)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketofol Group (Ketamine + Propofol)
Patients will take bolus dose of Propofol 0.25 mg/kg + Ketamine 0.25mg/kg If patient NOT sedated and need additional doses will be given another Propofol 0.25 mg/kg + Ketamine 0.25mg/kg IV
Drug: Ketofol
Patients will take bolus dose of Propofol 0.25 mg/kg + Ketamine 0.25mg/kg If patient NOT sedated and need additional doses will be given another Propofol 0.25 mg/kg + Ketamine 0.25mg/kg IV
Experimental: Propofol group ( propofol monotherapy)
Patients will take Propofol lowest bolus dose of 0.5 mg/kg IV as monotherapy. If patient NOT sedated and need additional doses will be given another dose of 0.25 to 0.5 mg/kg after hemodynamically assessment
Drug: propofol (drug)
Propofol given normal doses for intubation but at reduced and gradual dosing regimen regarding geriatric patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean arterial blood pressure
Time Frame: baseline then at 1, 3, 5, 10, 20, 30, and 60 minutes, then hourly for 24 hours
hemodynamic stability, defined as MAP measured Baseline then during and post intubation at 1min , 3min , 5min 10min, 20min , 30min , 60min then hourly for 24h.
baseline then at 1, 3, 5, 10, 20, 30, and 60 minutes, then hourly for 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to successful intubation
Time Frame: within 1 hours
Time to successful intubation (from induction to tube placement confirmation
within 1 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helwan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

March 28, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10H2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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