Clinical trial NCT06733129: Best Hypnotic Drug Choice for Rapid Sequence Induction in the Operating Room
Official title: Best Hypnotic Drug Choice for Rapid Sequence Induction in the Operating Room: a 3-arm Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Rapid Sequence Induction
Keywords: Rapid sequence induction
Full stomach patient
hypotension
propofol
ketamine
ketofol
general anesthesia
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 1218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

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

Primary outcomes:
measure: proportion of patients with successful intubation at first attempt and without post-induction hypotension
timeFrame: within 10 minutes after the start of the hypnotic injection
Secondary outcomes:
measure: rates of arterial hypotension episodes
timeFrame: within 10 minutes after the start of the hypnotic injection
measure: rates of tracheal intubation at the first attempt
timeFrame: within 10 minutes after the start of the hypnotic injection
measure: quality of the intubation
timeFrame: within 10 minutes after the start of the hypnotic injection
measure: quality of the intubation
timeFrame: within 10 minutes after the start of the hypnotic injection
measure: rates of vasopressor use
timeFrame: within 10 minutes after the start of the hypnotic injection
measure: time between administration of hypnotic and tracheal intubation
timeFrame: within 10 minutes after the start of the hypnotic injection
measure: values of heart rate
timeFrame: within 10 minutes after the start of the hypnotic injection
measure: values of SpO2
timeFrame: within 10 minutes after the start of the hypnotic injection
measure: values of blood pressure
timeFrame: within 10 minutes after the start of the hypnotic injection
measure: rates of pulmonary aspiration of gastric contents
timeFrame: within 10 minutes after the start of the hypnotic injection
measure: Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol
timeFrame: during stay in the recovery room
measure: Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol
timeFrame: during stay in the recovery room
measure: Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol
timeFrame: within 7 days after the start of the hypnotic injection
Other outcomes:
Locations:
city: Angers
country: France
facility: Chr Angers
city: Brest
country: France
facility: CHRU de Brest Hôpital Cavale Blanche
city: Dijon
country: France
facility: CHU Dijon
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: Le Kremlin-Bicêtre
country: France
facility: APHP Bicêtre
city: Le Mans
country: France
facility: CH Le Mans
city: Lille
country: France
facility: CHU Lille Hopital Salengro
city: Lille
country: France
facility: CHU Lille Hôpital Claude Huriez
city: Lyon
country: France
facility: CHU Lyon Hôpital Sud
city: Lyon
country: France
facility: HCL Lyon Croix-Rousse
city: Nantes
country: France
facility: Chu Nantes (Laennec)
city: Nantes
country: France
facility: Chu Nantes
city: Paris
country: France
facility: APHP St-Antoine
city: Paris
country: France
facility: APHP Tenon
city: Poitiers
country: France
facility: CHU Poitiers
city: Toulouse
country: France
facility: CHU Toulouse Hôpital Purpan
city: Toulouse
country: France
facility: CHU Toulouse Hôpital Rangueil
Study officials:
References: