The Critically Ill Patient is Requiring IntubationPhase 3NCT07530146

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

A Phase 3 study testing Ketofol and propofol (drug) in people with The Critically Ill Patient is Requiring Intubation and Septic Shock, run by Helwan University at 1 site in Egypt.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 65 years and older
Conditions the study is for: The Critically Ill Patient is Requiring Intubation, Septic Shock, Pneumonia
What is being tested?: Ketofol and propofol (drug)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteEgypt
Study dates: 13 May 2026to Oct 2026
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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.

Who cannot join

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

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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)

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Kasr Al Aini Hospital
Cairo

Other trials in Egypt

About this study

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) 5 minutes after induction

Secondary outcomes include changes in blood pressure and heart rate, incidence of hypotension, vasopressor requirements, sedation depth, pain scores, cumulative sedative and opioid consumption, adverse events, ICU length of stay, and ICU mortality at predefined intervals.

Conditions: The Critically Ill Patient is Requiring Intubation, Septic Shock, Pneumonia
Being tested: Ketofol, propofol (drug)
Keywords: ketofol, propofol, septic shock, pneumonia, geriatric, elderly, critical ill, ICU patient, intubation
Medical subject headings: Shock, Septic, Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT07530146
Study group	Role	What they receive
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 Receives: 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 Receives: Drug: propofol (drug)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (10)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 May 2026Oct 2026

First posted15 Apr 2026
Study start13 May 2026
Primary completion18 Sep 2026
Study completionOct 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for The Critically Ill Patient is Requiring IntubationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 70 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07530146
Sponsor's protocol ID: N-81-2026
Status last verified: Oct 2026
First submitted: 28 Mar 2026
Last updated: 15 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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.
PubMed 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.
PubMed 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.
PubMed 33262033