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Propofol, ketamine, or both? major trial seeks safer emergency intubation

NCT ID NCT06733129

Disease control Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial is testing three approaches to rapid sequence induction (RSI) in the operating room: propofol alone, ketamine alone, or a combination of both. The goal is to find which option gives the best balance—successful intubation on the first try without causing a dangerous drop in blood pressure. About 1,200 adults at risk of stomach contents entering the lungs will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
propofol, ketamine, and a combination of ketamine and propofol
What this could lead to
If it works, this could identify the best drug or drug combination to make emergency intubation safer and more stable for patients at risk of aspiration.
What could go wrong
This is a single-center trial, and results may not apply to all hospitals or patient groups. The primary outcome is a composite measure, so success in one part may not mean overall benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,218 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * age between 18 - 80 years' old * female\* and male * ≥ 1 risk factor of aspiration of gastric contents defined as * preoperative fasting period of less than 6 hours, * occlusive syndrome, functional ileus, vomiting episode within the last 12 hours, * orthopaedic trauma within the last 12 hours, * medical history of symptomatic gastroesophageal reflux or hiatus, hernia or gastroparesis or dysautonomia or gastroesophageal surgery with sphincter dysfunction) * patient requiring orotracheal intubation during general anaesthesia in the operating room. * patient or his/her next of kin written informed consent or emergency procedure * failure to discontinue GLP1 analogue as recommended (exenatide, liraglutide, albiglutide, taspoglutide, lixisenatide) Exclusion Criteria: * predicted impossible tracheal intubation (≥ 1 of the following criteria: patient with known intubation complications, Mallampati score IV, Thyromental Distance ≤ 4.0 cm, Mouth Opening \< 3 cm, Sternomental Distance \< 12.5 cm, significant modification of the airway due to congenital, cancer, trauma or burning lesions (non-exhaustive list)) \[30\] * preoperative arterial hypotension (MAP \< 65 mmHg or under catecholamine) * preoperative respiratory distress syndrome (SpO2 \< 90% in room air) * contraindications to the use of ketamine and/or propofol and/or NMB: * allergy to the active substance or to one of the excipients or to soy or peanuts, * porphyria * intracranial hypertension * uncontrolled arterial hypertension (systolic arterial pressure \> 180 mmHg) * personal or family history of known malignant hyperthermia, congenital muscular dystrophy, myasthenia, a known congenital deficit in plasma pseudocholinesterase * pregnancy or breast-feeding woman * patients under court protection or guardianship * absence of insurance covering health costs

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Conditions

The condition(s) this trial relates to.

hypotensive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rapid sequence induction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APHP Bicêtre

    NOT_YET_RECRUITING

    Le Kremlin-Bicêtre, France

  • APHP St-Antoine

    NOT_YET_RECRUITING

    Paris, France

  • APHP Tenon

    NOT_YET_RECRUITING

    Paris, France

  • CH Le Mans

    RECRUITING

    Le Mans, France

  • CHD Vendée

    RECRUITING

    La Roche-sur-Yon, France

  • CHRU de Brest Hôpital Cavale Blanche

    RECRUITING

    Brest, France

  • CHU Dijon

    RECRUITING

    Dijon, France

  • CHU Grenoble Alpes

    NOT_YET_RECRUITING

    Grenoble, France

  • CHU Lille Hopital Salengro

    RECRUITING

    Lille, France

  • CHU Lille Hôpital Claude Huriez

    RECRUITING

    Lille, France

  • CHU Lyon Hôpital Sud

    NOT_YET_RECRUITING

    Lyon, France

  • CHU Poitiers

    RECRUITING

    Poitiers, France

  • CHU Toulouse Hôpital Purpan

    NOT_YET_RECRUITING

    Toulouse, France

  • CHU Toulouse Hôpital Rangueil

    NOT_YET_RECRUITING

    Toulouse, France

  • Ch Louis Pasteur

    NOT_YET_RECRUITING

    Chartres, France

  • Chr Angers

    RECRUITING

    Angers, France

  • Chu Nantes

    RECRUITING

    Nantes, 44093, France

  • Chu Nantes (Laennec)

    RECRUITING

    Nantes, 44093, France

  • HCL Lyon Croix-Rousse

    NOT_YET_RECRUITING

    Lyon, France

  • Hopital Foch

    RECRUITING

    Suresnes, France

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