Actively Recruiting
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
Eligibility Criteria
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)
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
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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
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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