Best Hypnotic Drug Choice for Rapid Sequence Induction in the Operating Room: a 3-arm Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,218
- 试验地点
- 20
- 主要终点
- proportion of patients with successful intubation at first attempt and without post-induction hypotension
研究概览
简要总结
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.
Therefore, a randomized study evaluating the efficacy of propofol, ketamine, and a combination of both is appropriate. So, we designed the HyPnotiKs randomized controlled study to investigate the efficacy of these hypnotic drugs in patients undergoing RSI in the operating theatre. The primary endpoint will be the successful tracheal intubation at the first attempt without major arterial hypotension event.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 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)
- •patient requiring orotracheal intubation during general anaesthesia in the operating room.
- •patient or his/her next of kin written informed consent or emergency procedure
- •failure to discontinue GLP1 analogue as recommended (exenatide, liraglutide, albiglutide, taspoglutide, lixisenatide)
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)) [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
研究组 & 干预措施
KETOFOL
Ketofol: combination of Ketamine and Propofol : consecutive direct IV injection of Ketamine 1 mg/kg and Propofol 1 mg/kg after completing pre-oxygenation
干预措施: combination of Ketamine and Propofol (Drug)
KETAMINE
direct IV injection at dosage of 2 mg/kg after completing pre-oxygenation
干预措施: direct IV injection (Drug)
PROPOFOL
direct IV injection at dosage of 2 mg/kg after completing pre-oxygenation.
干预措施: direct IV injection (Drug)
结局指标
主要结局
proportion of patients with successful intubation at first attempt and without post-induction hypotension
时间窗: 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 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
- rates of arterial hypotension episodes(within 10 minutes after the start of the hypnotic injection)
- rates of tracheal intubation at the first attempt(within 10 minutes after the start of the hypnotic injection)
- volume of intravenous fluids for vascular filling(up to relapse of the recovery room (up to 7 days after surgery))
- quality of the intubation(within 10 minutes after the start of the hypnotic injection)
- time between administration of hypnotic and tracheal intubation(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)(within 10 minutes after the start of the hypnotic injection)
- values of heart rate(within 10 minutes after the start of the hypnotic injection)
- values of SpO2(within 10 minutes after the start of the hypnotic injection)
- values of blood pressure(within 10 minutes after the start of the hypnotic injection)
- rates of pulmonary aspiration of gastric contents(within 10 minutes after the start of the hypnotic injection)
- Tolerance of ketamine and / or ketamine-propofol combination compared to standard doses of propofol(within 7 days after the start of the hypnotic injection)