Kim Jeayoun, Lee Seungwon, Park Boram, Sim Woo Seog, Ahn Hyun Joo, Park Mi-Hye, Jeong Ji Seon
Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Biomedical Statistics Center, Research Institute for Future Medicine, Samsung Medical Center, Seoul, Korea.
Perioper Med (Lond). 2024 Jun 14;13(1):56. doi: 10.1186/s13741-024-00415-6.
Remimazolam is a short-acting benzodiazepine newly approved for the induction and maintenance of general anesthesia. Remimazolam emerges as an ideal drug for the neurosurgical population due to its rapid emergence, enabling early neurological assessment, and its ability to maintain perfusion pressure, which is crucial for preventing cerebral ischemia. However, the use of benzodiazepine has been associated with an increased risk of postoperative delirium (POD). There is currently limited evidence about the relationship between remimazolam-based total intravenous anesthesia (TIVA) and POD.
In this double-blind, randomized, non-inferiority trial, we plan to include 696 adult patients with American Society of Anesthesiologists physical status class I to III, undergoing elective neurovascular surgery under general anesthesia. After informed consent, the patients will be randomized to receive either remimazolam or propofol-based TIVA with a 1:1 ratio. The primary outcome is the incidence of POD within 5 days after surgery. Secondary outcomes include subtypes, number of positive assessments and severity of POD, emergence agitation, intraoperative awareness and undesirable patient movement, intraoperative hypotension, and postoperative cognitive function. The data will be analyzed in modified intention to treat.
This trial will evaluate the effect of remimazolam on the development of POD compared to propofol anesthesia. The results of this trial will provide evidence regarding the choice of optimal anesthetics to minimize the risk of POD in neurosurgical patients.
The study protocol was prospectively registered at the Clinical trials ( https://clinicaltrials.gov , NCT06115031, principal investigator: Jiseon Jeong; date of first registration: November 2, 2023, before the recruitment of the first participant.
瑞马唑仑是一种新批准用于全身麻醉诱导和维持的短效苯二氮䓬类药物。瑞马唑仑因其苏醒迅速，有利于早期进行神经功能评估，且具有维持灌注压的能力，而这对预防脑缺血至关重要，因此成为神经外科患者的理想药物。然而，使用苯二氮䓬类药物与术后谵妄（POD）风险增加有关。目前关于基于瑞马唑仑的全静脉麻醉（TIVA）与POD之间关系的证据有限。
在这项双盲、随机、非劣效性试验中，我们计划纳入696例美国麻醉医师协会身体状况分级为I至III级、在全身麻醉下接受择期神经血管手术的成年患者。在获得知情同意后，患者将按1:1的比例随机接受基于瑞马唑仑或丙泊酚的TIVA。主要结局是术后5天内POD的发生率。次要结局包括POD的亚型、阳性评估次数和严重程度、苏醒期躁动、术中知晓和患者不良活动、术中低血压以及术后认知功能。数据将采用改良意向性分析。
本试验将评估瑞马唑仑与丙泊酚麻醉相比对POD发生的影响。本试验结果将为选择最佳麻醉药物以降低神经外科患者POD风险提供证据。
该研究方案已在临床试验（https://clinicaltrials.gov，NCT06115031，主要研究者：Jeong Jiseon；首次注册日期：2023年11月2日，在招募第一名参与者之前）进行前瞻性注册。
