Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
NCT06733129

Best Hypnotic Drug Choice for Rapid Sequence Induction in the Operating Room

Led by Nantes University Hospital · Updated on 2025-12-02

1218

Participants Needed

20

Research Sites

106 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The best hypnotic choice to optimize the balance between good intubation condition quality and hemodynamic stability during RSI performed in the operating theatre remained to be investigated. Therefore, a randomized study evaluating the efficacy of propofol, ketamine, and a combination of both is appropriate. So, we designed the HyPnotiKs randomized controlled study to investigate the efficacy of these hypnotic drugs in patients undergoing RSI in the operating theatre. The primary endpoint will be the successful tracheal intubation at the first attempt without major arterial hypotension event.

CONDITIONS

Official Title

Best Hypnotic Drug Choice for Rapid Sequence Induction in the Operating Room

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years old
  • Female or male
  • At least one risk factor for aspiration of gastric contents such as fasting less than 6 hours, occlusive syndrome, vomiting within last 12 hours, recent orthopedic trauma, or history of gastroesophageal conditions
  • Patient requires orotracheal intubation during general anesthesia in the operating room
  • Patient or next of kin provides written informed consent or emergency procedure consent
  • Failure to discontinue GLP1 analogue as recommended (exenatide, liraglutide, albiglutide, taspoglutide, lixisenatide)
Not Eligible

You will not qualify if you...

  • Predicted impossible tracheal intubation due to known complications, Mallampati score IV, limited mouth opening, short thyromental or sternomental distance, or airway changes from congenital, cancer, trauma, or burns
  • Preoperative arterial hypotension (mean arterial pressure below 65 mmHg or on catecholamines)
  • Preoperative respiratory distress syndrome (oxygen saturation below 90% in room air)
  • Contraindications to ketamine, propofol, or neuromuscular blockers including allergies to active substances or excipients, porphyria, intracranial hypertension, uncontrolled high blood pressure, or history of malignant hyperthermia or muscular disorders
  • Pregnancy or breastfeeding
  • Patients under court protection or guardianship
  • Lack of health insurance coverage

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 20 locations

1

Chr Angers

Angers, France

Actively Recruiting

2

CHRU de Brest Hôpital Cavale Blanche

Brest, France

Actively Recruiting

3

Ch Louis Pasteur

Chartres, France

Not Yet Recruiting

4

CHU Dijon

Dijon, France

Actively Recruiting

5

CHU Grenoble Alpes

Grenoble, France

Not Yet Recruiting

6

CHD Vendée

La Roche-sur-Yon, France

Actively Recruiting

7

APHP Bicêtre

Le Kremlin-Bicêtre, France

Not Yet Recruiting

8

CH Le Mans

Le Mans, France

Actively Recruiting

9

CHU Lille Hopital Salengro

Lille, France

Actively Recruiting

10

CHU Lille Hôpital Claude Huriez

Lille, France

Actively Recruiting

11

CHU Lyon Hôpital Sud

Lyon, France

Not Yet Recruiting

12

HCL Lyon Croix-Rousse

Lyon, France

Not Yet Recruiting

13

Chu Nantes (Laennec)

Nantes, France, 44093

Actively Recruiting

14

Chu Nantes

Nantes, France, 44093

Actively Recruiting

15

APHP St-Antoine

Paris, France

Not Yet Recruiting

16

APHP Tenon

Paris, France

Not Yet Recruiting

17

CHU Poitiers

Poitiers, France

Actively Recruiting

18

Hopital Foch

Suresnes, France

Actively Recruiting

19

CHU Toulouse Hôpital Purpan

Toulouse, France

Not Yet Recruiting

20

CHU Toulouse Hôpital Rangueil

Toulouse, France

Not Yet Recruiting

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Research Team

N

Nicolas GRILLOT, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Best Hypnotic Drug Choice for Rapid Sequence Induction in the Operating Room | DecenTrialz