2025-521602-18-00
尚未招募
2 期
Efficacy and safety of Remimazolam compared to Ketamine and Propofol in Rapid Sequence Induction. A monocentric pilot randomised-controlled study
Centre Hospitalier Universitaire De Nantes1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年1月6日最近更新:
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Centre Hospitalier Universitaire De Nantes
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- proportion of patient with successful intubation at first attempt
概览
简要总结
to compare the ability of remimazolam to standard doses of propofol and ketamine to achieve successful tracheal intubation on the first attempt 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（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •female and male between 18 – 80 years’ old
- •≥ 1 risk factor of aspiration of gastric contents defined as o preoperative fasting period of less than 6 hours, o occlusive syndrome, functional ileus, vomiting episode within the last 12 hours, o orthopaedic trauma within the last 12 hours, o 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
排除标准
- •Refusal to participate
- •Patient unable to understand spoken or written French
- •Predicted impossible tracheal intubation
- •Preoperative hemodynamic shock (MAP < 65 mmHg or under catecholamine)
- •Preoperative consciousness disorder (GCS < 12/15)
- •Preoperative respiratory distress syndrome (SpO2 < 90% in room air)
- •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)
- •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
proportion of patient with successful intubation at first attempt
proportion of patient with successful intubation at first attempt
次要结局
- 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
- 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)
- 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
- 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
- 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
- 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
- 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
- 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)
- 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)
- 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
- In the recovery room compared between the three study groups: postoperative Nu-DESC score median value
- In the recovery room compared between the three study groups: percentage of patient requiring sedative therapy in recovery room assigned with delirium
- Up to day 7 compared between the 3 groups: percentage of patient with major cardiovascular complications
- Up to day 7 compared between the three study groups: percentage of patient with postoperative acute renal failure at day 7
- Up to day 7 compared between the three study groups:intra-hospital mortality
- Up to day 7 compared between the three study groups: survival proportion at day 7
研究者
Raphaël CINOTTI
Scientific
Centre Hospitalier Universitaire De Nantes
研究点 (1)
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