2024-517582-16-00招募中3 期
Best hypnotic drug choice for rapid sequence induction in the operating room: a 3-arm randomized trial open-labelled with blinded evaluation of the primary outcome
Centre Hospitalier Universitaire De Nantes16 个研究点 分布在 1 个国家目标入组 1,218 人开始时间: 2025年3月14日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,218
- 试验地点
- 16
- 主要终点
- 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.
研究概览
简要总结
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 severe hemodynamic hypotension in patients at risk of aspiration of gastric contents in the operating room
研究设计
- 分配方式
- Randomized
- 主要目的
- Overall Trial
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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, failure to discontinue GLP1 analogue as recommended (exenatide, liraglutide, albiglutide, taspoglutide, lixisenatide)
- •patient requiring orotracheal intubation during general anaesthesia in the operating room
- •patient or his/her next of skin written informed consent or emergency procedure
排除标准
- •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))
- •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
- •pregnancy or breast-feeding woman
- •patients under court protection or guardianship
- •absence of insurance covering health costs
结局指标
主要结局
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.
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.
次要结局
- 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
- 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
- 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)
- 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
- 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
- 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
- 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)
- 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
- 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.
- 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
- 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
- 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 failure of tracheal intubation after the first attempt
- 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.
研究者
Dr Nicolas GRILLOT
Scientific
Centre Hospitalier Universitaire De Nantes
研究点 (16)
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