Efficacy and Safety Evaluation of Injectable Remimazolam for Intraoperative Arousal in Scoliosis Orthopedics
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 148
- 主要终点
- Mean time to arousal
研究概览
简要总结
Spinal cord injury is one of the most dangerous complications of scoliosis orthopedic surgery, and the Stagnara awakening test has been used in orthopedic spine surgery and is considered the "gold standard" for detecting spinal cord injury. During the awakening test, the patient is awakened from anesthesia and, in conjunction with a neurological assessment, moves his or her fingers and toes to determine the integrity of spinal cord motor function in order to avoid spinal cord injury. During this procedure, the patient still requires a degree of sedation and analgesia to tolerate tracheal intubation and surgical pain. Remazolam benzoate for injection is a new class of benzodiazepines that are ultra-short-acting sedative/anesthetic drugs. It has the advantages of rapid onset, rapid elimination, and no drug accumulation by continuous infusion, and has the advantage of being applied to wake up during spinal orthopedic surgery, but its effectiveness and safety are still unclear. This study aims to elucidate the safety and efficacy of rimazolam benzoate for injection for arousal in spinal orthopedic surgery through a single-center, randomized, single-blind, positive drug-controlled trial, with the aim of providing a basis for the development of a safe and effective anesthetic protocol for such surgery.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years and less than 60 years
- •Elective scoliosis orthopaedic surgery under general anesthesia.
- •ASA Physical Score I-III
- •Signed informed consent.
排除标准
- •Patients who cannot understand the method and requirements of the arousal test and cannot cooperate in completing the arousal test.
- •Patients with limb sensory-motor dysfunction.
- •Patients with a history of severe neurological disorders.
- •Patients with psychiatric disorders.
- •Patients who have taken benzodiazepines and/or opioids daily for one month or intermittently for the last three months.
- •Patients with concomitant severe respiratory and circulatory disorders, including acute heart failure, unstable angina, resting ECG heart rate <50 beats/min, QTc: ≥ 470ms in men and ≥ 480ms in women, third-degree AV block, severe arrhythmia, moderate to severe heart valve disease, chronic obstructive pulmonary disease, and history of asthma.
- •Abnormal liver and kidney function: ALT and/or AST exceeding 2.5 times the upper limit of the medical reference range; urea or urea nitrogen ≥1.5 × ULN, blood creatinine greater than the upper limit of normal values.
研究组 & 干预措施
remimazolam group
For induction of anesthesia, rimazolam benzoate was pumped at a rate of 12 mg/kg/h; for maintenance of anesthesia, 1.0-2.0 mg/kg/h rimazolam was given as a continuous pump.
干预措施: Remimazolam (Drug)
propoful group
For induction of anesthesia, propofol medium-length chain fatty milk injection 2 mg/kg was given by intravenous push; for maintenance of anesthesia, 6-8 mg/kg/h propofol medium-length chain fatty milk injection was given by continuous pumping.
干预措施: Propofol (Drug)
结局指标
主要结局
Mean time to arousal
时间窗: Perioperative period
the time between the cessation of intraoperative drug infusion and the subject's ability to move the toes on command.
次要结局
- Quality of arousal(Perioperative period)
- Mean time from initiation of dosing to MOAA/S score ≤1(Perioperative period)
- Mean time from discontinuation at the end of surgery to full awakening of the subject(Perioperative period)
- Proportion of successful induction of anesthesia(Perioperative period)
- EEG characteristics during the induction, maintenance and awakening periods(Perioperative period)
研究者
Anshi Wu
Director of department of anesthesiology, Chaoyang Hospital
Beijing Chao Yang Hospital