Effects of Alternating Ciprofol and Remimazolam on Intraoperative Motor and Somatosensory Evoked Potentials During Spine Surgery: A Randomized Crossover Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Within-participant difference in lower-extremity MEP peak-to-peak amplitude between ciprofol and remimazolam periods
研究概览
简要总结
Intraoperative neurophysiological monitoring, including motor evoked potentials and somatosensory evoked potentials, is commonly used during spine surgery to help detect impending neurological injury. The quality of these signals can be affected by anesthetic agents. Ciprofol and remimazolam are newer intravenous hypnotic agents that may be suitable for total intravenous anesthesia during procedures requiring neurophysiological monitoring, but direct within-patient comparisons between the two agents are lacking. This single-center, prospective, randomized, two-sequence crossover trial will compare the effects of ciprofol and remimazolam, administered with remifentanil, on intraoperative MEP and SEP signal quality during spine surgery. Eligible participants will be randomized to receive either ciprofol followed by remimazolam or remimazolam followed by ciprofol during predefined stable intraoperative monitoring windows. The primary outcome is the within-participant difference in lower-extremity MEP peak-to-peak amplitude between the ciprofol and remimazolam periods. Secondary outcomes include SEP amplitude and latency, MEP latency, warning-threshold events, hemodynamic variables, rescue medication requirements, recovery characteristics, and postoperative neurological status.
详细描述
MEP and SEP monitoring are important components of intraoperative neurophysiological monitoring during complex spine surgery. However, evoked potential amplitudes and latencies are influenced not only by neurological injury but also by anesthetic depth, hypnotic agents, opioids, blood pressure, temperature, carbon dioxide, residual neuromuscular blockade, stimulation parameters, patient positioning, and surgical stage. Total intravenous anesthesia is therefore commonly preferred when reliable MEP monitoring is required. Ciprofol is a propofol analogue acting mainly on GABAA receptors and may provide sedation or anesthesia with less circulatory depression in some settings. Remimazolam is a short-acting benzodiazepine metabolized by tissue esterases and can be antagonized by flumazenil. Existing studies have compared each drug with propofol or reported successful MEP monitoring under remimazolam, but there is no direct randomized crossover comparison of ciprofol and remimazolam during spine surgery requiring MEP and SEP monitoring. In this trial, each participant will serve as his or her own control. Participants will be randomized in a 1:1 ratio to one of two sequences: ciprofol followed by remimazolam or remimazolam followed by ciprofol. Both study periods will be conducted under remifentanil-based analgesia and similar targets for anesthetic depth, hemodynamics, ventilation, temperature, and neuromuscular recovery. MEP and SEP recordings will be obtained during stable intraoperative windows before and after drug transition. The study aims to determine whether one agent provides more favorable neurophysiological monitoring signal quality while maintaining acceptable hemodynamic stability and surgical conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The attending anesthesiologist cannot be fully masked because the study drugs require different preparation and infusion strategies. Intraoperative neurophysiological monitoring interpreters, data abstractors, and statistical analysts will be blinded to the coded drug sequence whenever feasible.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years.
- •Scheduled to undergo elective spine surgery.
- •Planned intraoperative monitoring with MEP and SEP/SSEP.
- •Expected surgical duration sufficient to complete two study drug periods and intraoperative monitoring windows, preferably at least 3.5 to 4 hours.
- •American Society of Anesthesiologists physical status I to III.
- •Able to provide written informed consent, or consent provided by a legally authorized representative where applicable.
排除标准
- •Known allergy or contraindication to ciprofol, remimazolam, benzodiazepines, propofol-related formulations, opioids, or relevant excipients.
- •Severe preoperative motor or sensory deficit preventing interpretable target MEP or SEP baseline recordings.
- •Implanted cardiac pacemaker, skull defect, or other condition considered unsuitable for transcranial electrical stimulation.
- •Severe neuromuscular disease, poorly controlled epilepsy, severe cognitive impairment, or inability to complete postoperative neurological assessment.
- •Severe hepatic or renal dysfunction, severe hemodynamic instability, shock, or requirement for high-dose vasoactive medications before enrollment.
- •Long-term benzodiazepine, sedative-hypnotic, antiepileptic drug use, or drug/alcohol dependence that may substantially alter anesthetic response.
- •Expected need for continuous deep neuromuscular blockade during surgery, preventing valid MEP monitoring.
- •Any other condition judged by the investigators to make participation unsuitable or unsafe.
结局指标
主要结局
Within-participant difference in lower-extremity MEP peak-to-peak amplitude between ciprofol and remimazolam periods
时间窗: During surgery, at predefined stable monitoring windows under each study drug; up to 6 hours
Lower-extremity target-muscle motor evoked potential peak-to-peak amplitudes will be recorded during stable intraoperative monitoring windows under ciprofol and remimazolam. The primary analysis will compare log-transformed MEP amplitude or amplitude ratio between the two drug periods within the same participant.
次要结局
- Within-participant difference in lower-extremity SEP amplitude(During surgery, at predefined stable monitoring windows under each study drug; up to 6 hours)
研究者
Jiawei Jiang
Dr
Affiliated 2 Hospital of Nantong University