Effect of Remimazolam Versus Propofol Anesthesia on Postoperative Delirium in Neurosurgical Patients: A Randomised, Controlled, Noninferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 696
- 试验地点
- 1
- 主要终点
- Postoperative delirium
研究概览
简要总结
The investigator aimed to evaluate the incidence of postoperative delirium after remimazolam-based total intravenous anesthesia (TIVA) compared to the propofol-based TIVA in patients undergoing neurosurgery.
详细描述
Remimazolam, a short-acting benzodiazepine, has recently gained approval for use in the induction and maintenance of general anesthesia. In American Society of Anesthesiologists (ASA) physical status class I and II patients undergoing general anesthesia, the remimazolam-based TIVA has shown comparable efficacy to propofol-based TIVA while demonstrating a superior safety profile. Remimazolam has exhibited a lower incidence of hypotension, reduced vasopressor requirements, and fewer instances of bradycardia compared to the propofol-based TIVA.
The use of benzodiazepine has been associated with an increased risk of postoperative delirium, but there is currently no randomized controlled trial investigating the relationship between remimazolam, a new short-acting benzodiazepine, and postoperative delirium. Therefore, the investigators designed this prospective, randomized, double-blinded, active comparator-controlled, non-inferiority trial to investigate the incidence of postoperative delirium after remimazolam-based TIVA compared with propofol-based TIVA in neurosurgery patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status class I - III
排除标准
- •Severe respiratory, cardiovascular, or hepatic disease (Child-Pugh C)
- •Dependency on psychiatric drugs or alcohol
- •Severe sensory impairments that impede communication
- •Preoperative delirium
- •Hypersensitivity, allergies, or contraindication to the study drugs.
研究组 & 干预措施
Remimazolam
General anesthesia using continuous infusion of intravenous remimazolam and remifentanil. Remimazolam will be used for maintenance of general anesthesia and adjusted between 0.6-2mg/kg/hr until the end of surgery.
干预措施: Remimazolam (Drug)
Propofol
General anesthesia using target-controlled infusion of intravenous propofol and remifentanil. Propofol will be adjusted maintaining the BIS between 40-60 until the end of surgery.
干预措施: Propofol (Drug)
结局指标
主要结局
Postoperative delirium
时间窗: assessed up to postoperative day 5 or patient discharge, whichever came first
The occurrence of postoperative delirium, defined as at least one positive assessment during the postoperative period. Delirium will be assessed twice a day using confusion assessment method for the intensive care unit (CAM-ICU) and 3-minute diagnostic assessment for CAM-defined delirium (3D-CAM). These are binary diagnostic instruments (delirium present vs absent), not scored scales.
次要结局
- Onset of postoperative delirium(From the end of surgery until the date of first diagnosis of delirium or discharge, whichever came first, assessed up to postoperative day 5)
- Delirium symptoms(assessed twice a day up to postoperative day 5 or patient discharge, whichever came first)
- The proportion of valid delirium assessment(assessed twice a day up to postoperative day 5 or patient discharge, whichever came first)
- Delirium subtypes(assessed twice a day up to postoperative day 5 or patient discharge, whichever came first)
- Undesirable patient movement(Intraoperative period)
- Perioperative serious adverse events(rom date of randomization until 24 hour after surgery)
- Subsyndromal delirium(assessed twice a day up to postoperative day 5 or patient discharge, whichever came first)
- Postoperative pain score(assessed once a day up to postoperative day 5 or patient discharge, whichever came first)
- Functional status(3-month after surgery)
- Death(during hospitalization (up to day 30), within 1 year after surgery (3, 6, and 12-month after surgery))
- Duration of postoperative delirium(assessed twice a day up to postoperative day 5 or patient discharge, whichever came first)
- Intensive care unit (ICU) admission with endotracheal intubation after surgery(assessed up to postoperative day 5 or patient discharge, whichever came first)
- Opioid consumption(assessed once a day up to postoperative day 5 or patient discharge, whichever came first)
- Potential adverse event(From the beginning of anesthesia until 24 hours after surgery)
- Postoperative complication(Until 30 day after surgery)
- Length of stay in ICU after surgery(from the day of surgery to the time of patient discharge from ICU, assessed up to 3 months after surgery)
- Length of stay in hospital after surgery(from the day of surgery to the time of patient discharge, assessed up to 3 months after surgery)
- Acute kidney injury (AKI) after surgery(within 1 week after surgery)
- Postoperative cognitive dysfunction(3-month after surgery)
- Myocardial injury after non-cardiac surgery (MINS)(within 1-month after surgery)
- Fall(3-month after surgery)
- Severity of postoperative delirium(assessed twice a day up to postoperative day 5 or patient discharge, whichever came first)
- Emergence agitation(within 30 min after extubation)
- Intraoperative awareness(at postoperative day 0)
- Duration of postoperative delirium(from the end of surgery to the postoperative day 5)
- delayed extubation(Up to 1 hour after surgery)
- Undesirable patient movement(During surgery)
- Intraoperative adverse events(During surgery)
- Intraoperative hypotension(During surgery)
- Quality of early recovery(postoperative day 1)
- Postoperative complication(Up to 30 days after surgery)
- Fall(3-months after surgery)
- Postoperative cognitive dysfunction(postoperative day 7, 3-months after surgery)
- Functional status(3-months after surgery)
研究者
Jiseon Jeong
Associate professor
Samsung Medical Center