Evaluation of REMIFENTANIL as an alternative to curare for rapid sequence anesthetic induction in patients at risk of gastric fluid inhalation

INTERVENTION: Trade Name: REMIFENTANIL Pharmaceutical Form: Powder for solution for injection/infusion Product Name: Suxamethonium 50 mg/ml solution injectable Product Code: PRD7135239 Pharmaceutical Form: Solution for injection INN or Proposed INN: SUXAMETHONIUM CHLORIDE CAS Number: 71‐27‐2 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50‐ Product Name: Rocuronium 10 mg/ml solution injectable Product Code: PRD7135240 Pharmaceutical Form: Solution for injection INN or Proposed INN: 119302‐91‐9 Other descriptive name: ROCURONIUM BROMIDE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ CONDITION: anesthetic induction ; MedDRA version: 20.0 Level: LLT Classification code 10002326 Term: Anesthetic induction System Organ Class: 100000004865 Therapeutic area: Not possible to specify PRIMARY OUTCOME: Main Objective: The main objective of the study is to demonstrate the non‐inferiority of a rapid sequence anesthetic induction without curare with remifentanil on the prevention of major complications related to tracheal intubation compared to a rapid sequence induction with curare of short duration of action. Primary end point(s): The main criteria is the rate of tracheal intubation without major complications defined by the combination of the following criteria: ; 1) Tracheal intubation after = 2 laryngoscopies; 2) Absence of gastric fluid inhalation through the vocal cords within 10 minutes of anesthetic induction; 3) Absence of desaturation defined by SpO2 < 95% within 10 minutes of anesthetic induction.; 4) Absence of severe hemodynamic instability defined as hypotension (WFP = 50 mmHg) or hypertension (WFP = 110 mmHg) within 10 minutes of anesthetic induction; 5) Absence of a sustained ventricular rhythm disorder (i.e., requiring pharmacological or electrical intervention to reduce or last more than 30 seconds), ventricular fibrillation or cardiac arrest within 10 minutes of anesthetic induction; 6) Absence of a Grade III or IV anaphylactic reaction of the 2013 HAS classification within 10 minutes of the anesthetic induction; Secondary Objective: The secondary objectives are ; 1) Compare the effectiveness of rapid sequence intubation with or without rapid action curares; 2) Compare the tolerance of induction of rapid sequence induction with or without rapid action curares; 3) Compare the ability to prevent post‐operative respiratory complications; Timepoint(s) of evaluation of this end point: within 10 minutes of anesthetic induction SECONDARY OUTCOME: Secondary end point(s): The secondary evaluation criteria are: ; ; 1. Intubation quality score (IDS‐3 score); 2. The Cormack‐Lehane and POGO score values; 3. The frequency of patients for whom a technique to assist tracheal intubation was required; 4. The time between the administration of the hypnotic (beginning of anesthetic induction) and the achievement of the 6th capnography curve (effective tracheal intubation); 5. The frequency of patients who have had desaturation between 95% and 80% and < 80% of SpO2 within 10 minutes of anesthetic induction.; 6. The frequency of patients with severe hemodynamic disorder defined as a heart rate of less than 45 bpm and/or a heart rate of more than 110 bpm and/or a PAS of less than 80 mmHg and/or a PAS of more than 160 mmHg and/or a MAP of less than 55 mmHg and/or a MAP of more than 100 mmHg within 10 minutes of the anaesthetic induction.; 7. The frequency of patients with dental or tracheal lesions (endoscopic confirmation for the latter); 8. The frequency of patients who have had a Grade I or II allergic event of the 2013 HAS classification within 10 minutes of the anesthetic induction.; 9. Score POST values in SSPI at 1 hour post‐extubation (estimation of laryngeal lesions in immediate post‐operative care) ; ; Translated with www.DeepL.com/Translator Timepoint(s) of evaluation of this end point: Timepoints of evaluation of these end points are: ; ; 1. After intubation; 2. After intubation; 3. After intubation; 4. After intubation; 5. within 10 minutes of the anaesthetic induction; 6. within 10 minutes of the anaesthetic induction.; 7. After intubation; 8. within 10 minutes of the anesthetic induction.; 9. in immediate post‐operative care; INCLUSION CRITERIA: ‐ Female or male. ‐ Aged 18 to 80 years old ‐ Intervention requiring general anesthesia with orotracheal intubation ‐ Anesthetic management with indication of induction in rapid sequence ‐ Risk of gastric fluid inhalation defined by at least one of the following criteria: fasting period < 6:00 am, digestive obstruction, functional ileus, vomiting < 12:00 pm orthopedic trauma < 12:00 pm, history of severe GERD and/or hiatal hernia and/or gastroparesis and/or dysautonomy and/or gastroesophageal surgery ‐ Existence of informed and signed consent from the patient, or in the absence of an emergency procedure Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 850 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300