PROPOFOL for Rapid sequence induction

Inclusion criteria

• {"criterion_text":"- female and male between 18 – 80 years’ old"}
• {"criterion_text":"- ≥ 1 risk factor of aspiration of gastric contents defined as o\tpreoperative fasting period of less than 6 hours, o\tocclusive syndrome, functional ileus, vomiting episode within the last 12 hours, o\torthopaedic trauma within the last 12 hours, o\tmedical history of symptomatic gastroesophageal reflux or hiatus, hernia or gastroparesis or dysautonomia or gastroesophageal surgery with sphincter dysfunction)"}
• {"criterion_text":"- patient requiring orotracheal intubation during general anaesthesia in the operating room"}
• {"criterion_text":"- patient or his/her next of kin written informed consent or emergency procedure"}

Exclusion criteria

• {"criterion_text":"- Refusal to participate"}
• {"criterion_text":"- Patient unable to understand spoken or written French"}
• {"criterion_text":"- Predicted impossible tracheal intubation"}
• {"criterion_text":"- Preoperative hemodynamic shock (MAP < 65 mmHg or under catecholamine)"}
• {"criterion_text":"- Preoperative consciousness disorder (GCS < 12/15)"}
• {"criterion_text":"- Preoperative respiratory distress syndrome (SpO2 < 90% in room air)"}
• {"criterion_text":"- Contraindications to the use of remimazolam and/or 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, recent stroke, unstable coronary artery disease, severe heart failure, personal or family history of known malignant hyperthermia, congenital muscular dystrophy, myasthenia, a known congenital deficit in plasma pseudocholinesterase, liver failure defined as Child-Pugh classification C, uncontrolled arterial hypertension (systolic arterial pressure > 180 mmHg)"}
• {"criterion_text":"- Pregnancy or breast-feeding woman"}
• {"criterion_text":"- Patients under court protection or guardianship"}
• {"criterion_text":"- Absence of insurance covering health costs"}

Primary endpoints

• {"endpoint_text":"- proportion of patient with successful intubation at first attempt","definition_or_measurement_approach":"Measured as the proportion of patients with successful tracheal intubation at the first attempt."}

Secondary endpoints

• {"endpoint_text":"- In the operating theatre (within 5 minutes after induction of anesthesia) compared between the three study groups:median intubation quality score (IDS-3) values, median Cormack-Lehane score values and median (POGO) score values","definition_or_measurement_approach":"Measured in the operating theatre within 5 minutes after induction: median IDS-3, median Cormack-Lehane and median POGO scores compared between groups."}
• {"endpoint_text":"- In the operating theatre (within 5 minutes after induction of anesthesia) compared between the three study groups: median time between start of pre-oxygenation, administration of hypnotic (start of anesthetic induction), administration of NMB, initiation of first laryngoscopy and tracheal intubation (defined as the 6th capnography curve) (minutes)","definition_or_measurement_approach":"Measured in the operating theatre within 5 minutes after induction: median times (minutes) between pre-oxygenation, hypnotic administration, NMB administration, first laryngoscopy and tracheal intubation (6th capnography curve)."}
• {"endpoint_text":"- In the operating theatre (within 5 minutes after induction of anesthesia) compared between the three study groups: median value of heart rate, mean arterial pressure, SpO2 measured every minute from pre-oxygenation during the first 5 minutes after anesthetic induction","definition_or_measurement_approach":"Measured every minute from pre-oxygenation during first 5 minutes after induction: median heart rate, MAP, and SpO2 compared between groups."}
• {"endpoint_text":"- n the operating theatre (within 5 minutes after induction of anesthesia) compared between the three study groups: percentage of patient with pulmonary aspiration of gastric contents","definition_or_measurement_approach":"Measured in the operating theatre within 5 minutes after induction: percentage of patients with pulmonary aspiration of gastric contents."}
• {"endpoint_text":"- In the operating theatre (within 5 minutes after induction of anesthesia) compared between the three study groups: percentage of patient with moderate (SpO2 ≤ 95%) or severe (SpO2 ≤ 80%) desaturation during the first 5 minutes after anesthetic induction","definition_or_measurement_approach":"Measured in the operating theatre within 5 minutes after induction: percentage of patients with SpO2 ≤95% (moderate) or ≤80% (severe) during first 5 minutes."}
• {"endpoint_text":"- In the operating theatre (within 5 minutes after induction of anesthesia) compared between the three study groups: median minimal value of SpO2 value during the first 5 minutes after anesthetic induction","definition_or_measurement_approach":"Measured in the operating theatre within 5 minutes after induction: median minimal SpO2 during first 5 minutes."}
• {"endpoint_text":"- In the operating theatre (within 5 minutes after induction of anesthesia) compared between the three study groups: percentage of patients with major cardio-vascular events: major hemodynamic instability defined as mean arterial pressure ≤ 60mmHg (or ≤ 40% from the patient’s reference value) [16], heart rate < 45/mn, or systolic arterial pressure < 80 mmHg, cardiac arrythmia requiring pharmacological or external electric intervention or lasting more than 30 seconds","definition_or_measurement_approach":"Measured in the operating theatre within 5 minutes after induction: percentage of patients with major cardiovascular events defined by the specified hemodynamic and arrhythmia criteria."}
• {"endpoint_text":"- In the operating theatre (within 5 minutes after induction of anesthesia) compared between the three study groups: percentage of patients with anaphylaxis reaction (Grade of anaphylaxis reaction)","definition_or_measurement_approach":"Measured in the operating theatre within 5 minutes after induction: percentage of patients with anaphylaxis and grade of reaction."}
• {"endpoint_text":"- In the operating theatre (within 5 minutes after induction of anesthesia) compared between the three study groups: rates of vasopressor use and volume of intravenous fluids for vascular filling (from entry into the operating theatre to induction and from induction to recovery room)","definition_or_measurement_approach":"Measured from entry into operating theatre to induction and from induction to recovery room: rates of vasopressor use and volumes of IV fluids compared between groups."}
• {"endpoint_text":"- In the operating theatre (within 5 minutes after induction of anesthesia) compared between the three study groups: the total dose of hypnotic used during the first 5 minutes after anesthetic induction","definition_or_measurement_approach":"Measured in first 5 minutes after induction: total dose of hypnotic used compared between groups."}
• {"endpoint_text":"- In the recovery room compared between the three study groups: postoperative Nu-DESC score median value","definition_or_measurement_approach":"Measured in recovery room: median postoperative Nu-DESC score compared between groups."}
• {"endpoint_text":"- In the recovery room compared between the three study groups: percentage of patient requiring sedative therapy in recovery room assigned with delirium","definition_or_measurement_approach":"Measured in recovery room: percentage of patients requiring sedative therapy for delirium compared between groups."}
• {"endpoint_text":"- Up to day 7 compared between the 3 groups: percentage of patient with major cardiovascular complications","definition_or_measurement_approach":"Measured up to day 7: percentage of patients with major cardiovascular complications (e.g., cardiac arrest, sustained arrhythmia, MI, stroke) compared between groups."}
• {"endpoint_text":"- Up to day 7 compared between the three study groups: percentage of patient with postoperative acute renal failure at day 7","definition_or_measurement_approach":"Measured up to day 7: percentage of patients with postoperative acute renal failure at day 7 compared between groups."}
• {"endpoint_text":"- Up to day 7 compared between the three study groups:intra-hospital mortality","definition_or_measurement_approach":"Measured up to day 7: in-hospital mortality compared between groups."}
• {"endpoint_text":"- Up to day 7 compared between the three study groups: survival proportion at day 7","definition_or_measurement_approach":"Measured up to day 7: proportion of patients alive at day 7 compared between groups."}

France

Earliest CTIS Part Ii Submission Date

21-11-2025

Latest Decision Or Authorization Date

06-01-2026

Processing Time Days

46

Number Of Sites

2

Number Of Participants

90

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nantes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"VIATRIS","duties_or_roles":"Monetary support","organisation_type":""}