Informations générales (source: ClinicalTrials.gov)
Best Hypnotic Drug Choice for Rapid Sequence Induction in the Operating Room: a 3-arm Randomized Trial
Interventional
Phase 3
Nantes University Hospital (Voir sur ClinicalTrials)
avril 2025
avril 2027
02 décembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | MORGAN LEGUEN | 04/05/2026 07:26:40 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Saint Antoine | Franck VERDON | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Tenon | Franck VERDONK | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH Le Mans - Le Mans 3003603 - France | Laurent BLANCHET | Contact (sur clinicalTrials) | |||
| CHRU de Brest Hôpital Cavale Blanche - Brest 3030300 - France | Anais CAILLARD | Contact (sur clinicalTrials) | |||
| CHU Grenoble Alpes - Grenoble 3014728 - France | Pierre BOUZAT | Contact (sur clinicalTrials) | |||
| CHU Lille Hôpital Claude Huriez - Lille 2998324 - France | Cédric CIRENEI | Contact (sur clinicalTrials) | |||
| CHU Lille Hopital Salengro - Lille 2998324 - France | Nathalie BRUNEAU | Contact (sur clinicalTrials) | |||
| CHU Poitiers - Poitiers 2986495 - France | Quentin SAINT GENIS | Contact (sur clinicalTrials) | |||
| CHU Toulouse Hôpital Rangueil - Toulouse 2972315 - France | Francois LABASTE | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHP Bicêtre - Le Kremlin-Bicêtre 3003737 - France | Samy FIGUEIREDO | Contact (sur clinicalTrials) | |||
| Ch Louis Pasteur - Chartres 3026467 - France | Nidhal CHEBBI | Contact (sur clinicalTrials) | |||
| CHD Vendée - La Roche-sur-Yon 3006767 - France | Mathieu OUDOT | Contact (sur clinicalTrials) | |||
| Chr Angers - Angers 3037656 - France | Sigismond LASOCKI | Contact (sur clinicalTrials) | |||
| CHU Dijon - Dijon 3021372 - France | Pierre-Grégoire GUINOT | Contact (sur clinicalTrials) | |||
| CHU Lyon Hôpital Sud - Lyon 2996944 - France | Jean-Stephane DAVID | Contact (sur clinicalTrials) | |||
| Chu Nantes - 44093 - Nantes 2990969 - France | Nicolas GRILLOT, MD | Contact (sur clinicalTrials) | |||
| Chu Nantes (Laennec) - 44093 - Nantes 2990969 - France | Xavier AMBROSI | Contact (sur clinicalTrials) | |||
| CHU Toulouse Hôpital Purpan - Toulouse 2972315 - France | Maxime POMMIER | Contact (sur clinicalTrials) | |||
| HCL Lyon Croix-Rousse - Lyon 2996944 - France | Alice BLET | Contact (sur clinicalTrials) | |||
| Hopital Foch - Suresnes 2973675 - France | Morgan LE GUEN | Contact (sur clinicalTrials) | |||
Critères
Tous
- 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