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

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, 5, 10, 30, and then every 8h for 24 hours.

Study Overview

• Status: Recruiting
• Conditions: Pneumonia; Septic Shock; The Critically Ill Patient is Requiring Intubation
• Intervention / Treatment: Drug: Ketofol; Drug: propofol (drug)

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Kasr Al Aini Hospital
    • Contact: Ahmed Elsaeed Elshall; Phone Number: +201002998841; Email: dr.ahmedelshall@gmail.com
    • Contact: Email: malqaisoom@gmail.com
    • Principal Investigator: Mujtaba Alqaisoum

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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 pressure (MAP, mmHg) at 5 minutes	Mean arterial pressure (MAP, mmHg) at 5 minutes after administration of the induction agent	5 minutes post induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vasopressor escalation within 5 minutes		5 minutes
Peak norepinephrine dose within 5 minutes		5 minutes
Systolic blood pressure at 5 minutes after induction	Systolic blood pressure measured in mmHg	5 minutes after induction
Diastolic blood pressure at 5 minutes after induction	Diastolic blood pressure measured in mmHg	5 minutes after induction
Incidence of hypotension		Post-induction period
Pain intensity score	using CPOT score	within 24h
Sedation depth (RASS score)		From 30 minutes to 24 hours
Cumulative fentanyl consumption		During the study observation period
Adverse events	Incidence of Adverse events	During ICU follow-up
All-cause ICU mortality		During ICU stay

Collaborators and Investigators

• Sponsor: Helwan University

Publications and helpful links

General Publications

• Andolfatto G, Abu-Laban RB, Zed PJ, Staniforth SM, Stackhouse S, Moadebi S, Willman E. Ketamine-propofol combination (ketofol) versus propofol alone for emergency department procedural sedation and analgesia: a randomized double-blind trial. Ann Emerg Med. 2012 Jun;59(6):504-12.e1-2. doi: 10.1016/j.annemergmed.2012.01.017. Epub 2012 Mar 7.
• How to cite this article: Padhi S, Singh GP, Chaturvedi A, Rath GP. Effect of ketofol versus propofol on cerebral oxygenation in patients undergoing transsphenoidal pituitary surgery under total intravenous anesthesia - A randomized control trial. J Neurosci Rural Pract. 2025;16:S52-9. doi: 10.25259/JNRP_138_2025
• El Mourad MB, Shaaban AE, El Sharkawy SI, Afandy ME. Effects of Propofol, Dexmedetomidine, or Ketofol on Respiratory and Hemodynamic Profiles in Cardiac Patients Undergoing Transesophageal Echocardiography: A Prospective Randomized Study. J Cardiothorac Vasc Anesth. 2021 Sep;35(9):2743-2750. doi: 10.1053/j.jvca.2020.11.013. Epub 2020 Nov 10.
• Foo TY, Mohd Noor N, Yazid MB, Fauzi MH, Abdull Wahab SF, Ahmad MZ. Ketamine-propofol (Ketofol) for procedural sedation and analgesia in children: a systematic review and meta-analysis. BMC Emerg Med. 2020 Oct 8;20(1):81. doi: 10.1186/s12873-020-00373-4.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2026
• Primary Completion (Estimated): October 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): September 17, 2026
• Last Update Submitted That Met QC Criteria: September 14, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: septic shock; elderly; pneumonia; geriatric; propofol; intubation; ketofol; critical ill; ICU patient
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Lung Diseases; Shock; Pathological Conditions, Signs and Symptoms; Pneumonia; Shock, Septic; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Propofol; Pharmaceutical Preparations
• Other Study ID Numbers: N-81-2026

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