NCT07530146

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at below P25 for phase_3

Timeline
3mo left

Started Apr 2026

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Apr 2026Oct 2026

First Submitted

Initial submission to the registry

March 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

June 1, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

March 28, 2026

Last Update Submit

May 28, 2026

Conditions

The Critically Ill Patient is Requiring IntubationSeptic ShockPneumonia

Keywords

ketofolpropofolseptic shockpneumoniageriatricelderlycritical illICU patientintubation

Outcome Measures

Primary Outcomes (1)

  • Mean arterial blood pressure

    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 Outcomes (1)

  • Time to successful intubation

    within 1 hours

Study Arms (2)

Ketofol Group (Ketamine + Propofol)

EXPERIMENTAL

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

Propofol group ( propofol monotherapy)

EXPERIMENTAL

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)

Interventions

KetofolDRUG

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

Ketofol Group (Ketamine + Propofol)
propofol (drug)DRUG

Propofol given normal doses for intubation but at reduced and gradual dosing regimen regarding geriatric patient

Propofol group ( propofol monotherapy)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Badr University hospital in Cairo

Cairo, Cairo Governorate, 4942340, Egypt

RECRUITING

Kasr Al Aini Hospital

Cairo, Egypt

RECRUITING

Related Publications (4)

  • 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: 33032544BACKGROUND

  • 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

    BACKGROUND

  • 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: 22401952BACKGROUND

  • 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: 33262033BACKGROUND

Related Links

MeSH Terms

Conditions

Shock, SepticPneumonia

Interventions

PropofolPharmaceutical Preparations

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 28, 2026

First Posted

April 15, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

June 1, 2026

Record last verified: 2026-04

Locations

EG(2)