KETAMINE for Rapid sequence induction

Inclusion criteria

• {"criterion_text":"- age between 18 – 80 years’ old"}
• {"criterion_text":"- female and male"}
• {"criterion_text":"- ≥ 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, failure to discontinue GLP1 analogue as recommended (exenatide, liraglutide, albiglutide, taspoglutide, lixisenatide)"}
• {"criterion_text":"- patient requiring orotracheal intubation during general anaesthesia in the operating room"}
• {"criterion_text":"- patient or his/her next of skin written informed consent or emergency procedure"}

Exclusion criteria

• {"criterion_text":"- 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))"}
• {"criterion_text":"- preoperative arterial hypotension (MAP < 65 mmHg or under catecholamine)"}
• {"criterion_text":"- preoperative respiratory distress syndrome (SpO2 < 90% in room air)"}
• {"criterion_text":"- contraindications to the use of ketamine and/or propofol and/or NMB"}
• {"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":"- The composite primary outcome is the proportion of patients with successful intubation at first attempt and without post-induction hypotension defined by a mean arterial pressure ≤ 60 mmHg within 10 minutes after the start of the hypnotic injection.","definition_or_measurement_approach":"Proportion of patients meeting both criteria: (1) successful tracheal intubation on first attempt and (2) absence of post-induction hypotension; hypotension defined as mean arterial pressure (MAP) ≤ 60 mmHg within 10 minutes after start of the hypnotic injection."}

Secondary endpoints

• {"endpoint_text":"- compared between the three study groups : Components of the primary outcomes analyzed separately: 1/rates of arterial hypotension episodes as defined in primary endpoint within 10 minutes after induction of anaesthesia 2/rates of tracheal intubation at the first attempt","definition_or_measurement_approach":"Components of primary outcome analyzed separately: (1) rates of arterial hypotension episodes (MAP ≤ 60 mmHg) within 10 minutes after induction; (2) rates of tracheal intubation at first attempt."}
• {"endpoint_text":"- Related to secondary Aim (1). 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): intubation quality score (IDS-3) values, Cormack-Lehane score values and POGO score values","definition_or_measurement_approach":"Scores recorded in operating theatre within 10 minutes after hypnotic injection: IDS-3, Cormack-Lehane, and POGO scores."}
• {"endpoint_text":"- Related to secondary Aim (1). 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 capnography curve)","definition_or_measurement_approach":"Time interval from start of hypnotic administration to tracheal intubation (defined as 6th capnography curve), measured in operating theatre within 10 minutes window."}
• {"endpoint_text":"- Related to secondary Aim (1). 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, SpO2 and systolic/diastolic/mean arterial pressure measuredevery 1 minute from pre-oxygenation to 10 minutes after the start of the hypnotic injection","definition_or_measurement_approach":"Physiological parameters (heart rate, SpO2, systolic/diastolic/mean arterial pressure) recorded every 1 minute from pre-oxygenation to 10 minutes after start of hypnotic injection."}
• {"endpoint_text":"- Related to secondary Aim (1). 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","definition_or_measurement_approach":"Rate of pulmonary aspiration of gastric contents observed during intubation procedure in the operating theatre within 10 minutes after hypnotic injection."}
• {"endpoint_text":"- Related to secondary Aim (1). 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): minimal value of SpO2 value during the 10 first minutes after anaesthesia induction","definition_or_measurement_approach":"Minimum SpO2 recorded during first 10 minutes after anaesthesia induction in the operating theatre."}
• {"endpoint_text":"- Related to secondary Aim (1). 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 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":"Rates of vasopressor use and total volume of IV fluids for vascular filling measured from entry to operating theatre through induction and from induction to recovery room."}
• {"endpoint_text":"- Related to secondary Aim (2). Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol: In the recovery room: postoperative Nu-DESC score value compared with preoperative score","definition_or_measurement_approach":"Nu-DESC delirium scores in recovery room compared to preoperative baseline."}
• {"endpoint_text":"- Related to secondary Aim (2). Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol: In the recovery room: need of sedative therapy in the recovery room to treat a delirium episode.","definition_or_measurement_approach":"Need for sedative therapy in recovery room to treat delirium episodes (yes/no, recorded in recovery period)."}
• {"endpoint_text":"- Related to secondary Aim (2). Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol: Up to day 7: rates of major cardiovascular complications defined as: cardiac arrest, sustained arrhythmia, myocardial infarction, stroke (total, ischaemic, and haemorrhagic), coronary revascularization or admission to ICU for acute heart failure","definition_or_measurement_approach":"Rates of predefined major cardiovascular complications up to day 7 post-procedure (events as listed)."}
• {"endpoint_text":"- Related to secondary Aim (2). Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol: Up to day 7: rates of mortality at day 7","definition_or_measurement_approach":"All-cause mortality rate at day 7 post-procedure."}
• {"endpoint_text":"- Related to secondary Aim (1). 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): -\tates of failure of tracheal intubation after the first attempt","definition_or_measurement_approach":"Rate of failure of tracheal intubation after first attempt within operating theatre window."}
• {"endpoint_text":"- Related to secondary Aim (1). 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):Use of ketamine and total dose during intervention and total dose of ketamine in recovery room.","definition_or_measurement_approach":"Use and total dose of ketamine administered during the intervention and total ketamine dose in recovery room (quantitative dosing recorded)."}

France

Earliest CTIS Part Ii Submission Date

10-02-2025

Latest Decision Or Authorization Date

21-10-2025

Processing Time Days

253

Number Of Sites

22

Number Of Participants

1218

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Nantes

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France