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Recruiting NCT07530146

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

Phase III Interventional The Critically Ill Patient is Requiring Intubation Septic Shock Pneumonia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ketofol, propofol (drug).
Who it may be relevant to
Registry conditions: The Critically Ill Patient is Requiring Intubation, Septic Shock, Pneumonia. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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
  • Drug propofol (drug)
    Propofol given normal doses for intubation but at reduced and gradual dosing regimen regarding geriatric patient

Primary outcome measures

  • Mean arterial blood pressure [Time frame: baseline then at 1, 5, 10, , 30, and then every 8h for 24 hours]
Secondary outcome measures (1)
  • Heart Rate [Time frame: within 1 hours]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Kasr Al Aini Hospital — Cairo

Publications

  • 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. PMID 33032544
  • 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
  • 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. PMID 22401952
  • 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. PMID 33262033

Identifiers

NCT: NCT07530146 · N-81-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗