Best Hypnotic Drug Choice for Rapid Sequence Induction in the Operating Room
- Conditions
- Interventions
- Registration Number
- NCT06733129
- Lead Sponsor
- Nantes University Hospital
- 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.
...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1218
-
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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KETOFOL combination of Ketamine and Propofol Ketofol: combination of Ketamine and Propofol : consecutive direct IV injection of Ketamine 1 mg/kg and Propofol 1 mg/kg after completing pre-oxygenation KETAMINE direct IV injection direct IV injection at dosage of 2 mg/kg after completing pre-oxygenation PROPOFOL direct IV injection direct IV injection at dosage of 2 mg/kg after completing pre-oxygenation.
- Primary Outcome Measures
Name Time Method proportion of patients with successful intubation at first attempt and without post-induction hypotension within 10 minutes after the start of the hypnotic injection The main objective of the study is to compare the efficacies of ketamine alone and ketamine-propofol combination compared to standard doses of propofol to achieve successful tracheal intubation on the first attempt without hemodynamic hypotension in patients at risk of aspiration of gastric contents in the operating room. The composite primary outcome is the...
- Secondary Outcome Measures
Name Time Method rates of tracheal intubation at the first attempt within 10 minutes after the start of the hypnotic injection rates of tracheal intubation at the first attempt compared between the three study groups
rates of arterial hypotension episodes within 10 minutes after the start of the hypnotic injection rates of arterial hypotension episodes as defined in primary endpoint within 10 minutes after induction of anaesthesia compared between the three study groups
quality of the intubation within 10 minutes after the start of the hypnotic injection In the operating theatre (within 10 minutes after the start of the hypnotic injection): Cormack-Lehane score values (from 1 to 4)
* Cormack 1: The glottis is seen in its entirety
* Cormack 2: Only the posterior half of the glottis is seen
* Cormack 3: Only a small part of the glottis is seen
...rates of vasopressor use within 10 minutes after the start of the hypnotic injection In the operating theatre (within 10 minutes after the start of the hypnotic injection): rates of vasopressor use
time between administration of hypnotic and tracheal intubation within 10 minutes after the start of the hypnotic injection Efficacy of ketamine and / or ketamine-propofol combination compared to standard doses of propofol on the prevention of postoperative complications in the operating theatre (within 10 minutes after the start of the hypnotic injection) : - time between administration of hypnotic (start of anesthetic induction) and tracheal intubation (defined as the 6th capno...
values of heart rate within 10 minutes after the start of the hypnotic injection Efficacy of ketamine and / or ketamine-propofol combination compared to standard doses of propofol on the prevention of postoperative complications in the operating theatre (within 10 minutes after the start of the hypnotic injection) : values of heart rate measured every 1 minute from pre-oxygenation to 10 minutes after the start of the hypnotic injection
values of SpO2 within 10 minutes after the start of the hypnotic injection Efficacy of ketamine and / or ketamine-propofol combination compared to standard doses of propofol on the prevention of postoperative complications in the operating theatre (within 10 minutes after the start of the hypnotic injection): SpO2 measured every 1 minute from pre-oxygenation to 10 minutes after the start of the hypnotic injection
values of blood pressure within 10 minutes after the start of the hypnotic injection Efficacy of ketamine and / or ketamine-propofol combination compared to standard doses of propofol on the prevention of postoperative complications in the operating theatre (within 10 minutes after the start of the hypnotic injection): systolic/diastolic/mean blood pressure measured every 1 minute from pre-oxygenation to 10 minutes after the start of the hyp...
rates of pulmonary aspiration of gastric contents within 10 minutes after the start of the hypnotic injection Efficacy of ketamine and / or ketamine-propofol combination compared to standard doses of propofol on the prevention of postoperative complications in the operating theatre (within 10 minutes after the start of the hypnotic injection): rates of pulmonary aspiration of gastric contents during the intubation procedure
Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol within 7 days after the start of the hypnotic injection Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol in the recovery room:
Up to day 7:
...
Trial Locations
- Locations (18)
CHU Toulouse Hôpital Purpan
🇫🇷Toulouse, France
CHU Toulouse Hôpital Rangueil
🇫🇷Toulouse, France
CHU Poitiers
🇫🇷Poitiers, France
Chr Angers
🇫🇷Angers, France
CHRU de Brest Hôpital Cavale Blanche
🇫🇷Brest, France
CHU Dijon
🇫🇷Dijon, France
CHU Grenoble Alpes
🇫🇷Grenoble, France
CHD Vendée
🇫🇷La Roche-sur-Yon, France
APHP Bicêtre
🇫🇷Le Kremlin-Bicêtre, France
CH Le Mans
🇫🇷Le Mans, France
CHU Lille Hopital Salengro
🇫🇷Lille, France
CHU Lille Hôpital Claude Huriez
🇫🇷Lille, France
CHU Lyon Hôpital Sud
🇫🇷Lyon, France
HCL Lyon Croix-Rousse
🇫🇷Lyon, France
Chu Nantes (Laennec)
🇫🇷Nantes, France
Chu Nantes
🇫🇷Nantes, France
APHP St-Antoine
🇫🇷Paris, France
APHP Tenon
🇫🇷Paris, France