Ketamine Sedation in the ICU: A Comparison to Placebo in Mechanically Ventilated Adults
Official title: Ketamine Sedation in the Intensive Care Unit: a Pilot Randomized Controlled Trial
Run by McMaster University · NCT06767358 · Data updated 2026-11-12
This trial tests whether adding ketamine to standard sedation helps adults on a breathing tube in the ICU, compared with a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 54 (estimated) |
| Sponsor | McMaster University Academic / other |
| Locations | 3 sites (Hamilton, Ontario and 2 other locations) |
| Status | Recruiting |
| Started | November 20, 2025 |
| Main results expected | November 2027 |
| Study ends | December 2027 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT06767358 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult ICU patients (≥18) on invasive mechanical ventilation expected to remain ventilated beyond the day after randomization and currently ambulatory with non-ketamine sedatives.
✕Probably not a fit
Patients with certain critical conditions or risks, such as intracranial hemorrhage, stroke, severe hypertension, severe liver disease, or pregnancy, may not benefit and could be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, blinded, randomized pilot trial in four academic hospitals in Ontario.critically ill adults on invasive mechanical ventilation and requiring sedation are randomized to receive either ketamine hydrochloride or saline placebo as an adjunct to their usual sedatives. The primary goal is to determine feasibility for a larger trial, looking at consent, recruitment, and protocol adherence. Outcomes will inform whether a future Phase 3 study could evaluate effects on patient-important outcomes such as comfort, delirium, duration of mechanical ventilation, and ICU stay. The study uses centralized randomization and allocation concealment to minimize bias.
Why it matters
Potential benefit: If successful, ketamine could improve comfort and pain control while potentially reducing delirium and duration of mechanical ventilation.
How similar studies have gone: Prior use of ketamine in ICU settings suggests potential benefits, but large-scale ICU-specific effectiveness remains to be proven; this is a feasibility pilot to pave a larger trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (≥ 18 years) admitted to the ICU * Receiving invasive mechanical ventilation and expected to remain mechanically ventilated beyond the calendar day after randomization * Mechanically ventilated for fewer than 3 days * Receiving any non-ketamine continuous sedative infusion Exclusion Criteria: * Admitted with a primary diagnosis of intracranial hemorrhage, traumatic brain injury, or stroke * Admitted with uncontrolled hypertension (SBP/DBP \> 180/100mmHg) * Status asthmaticus * Admitted to the ICU with partial thickness burns \> 10% total body surface area or any full thickness burns * Schizophrenia * End-stage Liver Failure (Child-Pugh C) * Requiring an equivalent of norepinephrine at a dose ≥1mcg/kg/min * Undergoing palliation or comfort care * On neuromuscular blocking agent * Pre-existing tracheostomy * Hypersensitivity to Ketamine * Liver transplantation in the last month * Pregnant or breast-feeding
Where it's running
-
Hamilton Health Sciences
Hamilton, Ontario, Canada Recruiting -
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada Not yet recruiting -
Mount Sinai Hospital
Toronto, Ontario, Canada Not yet recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.