Ciprofol and Remimazolam for Intraoperative Neurophysiological Monitoring During Spine Surgery (CIRIONM)
2026년 7월 17일 업데이트: Jiawei Jiang, Affiliated 2 Hospital of Nantong University
Effects of Alternating Ciprofol and Remimazolam on Intraoperative Motor and Somatosensory Evoked Potentials During Spine Surgery: A Randomized Crossover Trial
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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
60
단계
- 4단계
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Ciprofol-Remimazolam Sequence
Participants assigned to this sequence will receive ciprofol-based total intravenous anesthesia during the first stable intraoperative monitoring period.
After the predefined first-period MEP and SEP recordings are completed, the hypnotic agent will be switched to remimazolam.
After an approximately 45- to 60-minute stabilization and washout period, second-period MEP and SEP recordings will be obtained under remimazolam-based anesthesia.
Remifentanil analgesia and standard physiologic targets will be maintained as consistently as clinically feasible across both periods.
|
Ciprofol will be administered intravenously for induction and/or maintenance according to the institutional anesthesia protocol and product labeling.
A suggested maintenance range is approximately 0.8 to 1.5 mg/kg/h, adjusted according to anesthetic depth, hemodynamics, surgical conditions, and patient safety.
Remimazolam will be administered intravenously for induction and/or maintenance according to the institutional anesthesia protocol and product labeling.
A suggested maintenance range is approximately 0.5 to 2 mg/kg/h or 1 to 2 mg/kg/h, adjusted according to anesthetic depth, hemodynamics, surgical conditions, body movement, and patient safety.
|
|
실험적: Remimazolam-Ciprofol Sequence
Participants assigned to this sequence will receive remimazolam-based total intravenous anesthesia during the first stable intraoperative monitoring period.
After the predefined first-period MEP and SEP recordings are completed, the hypnotic agent will be switched to ciprofol.
After an approximately 45- to 60-minute stabilization and washout period, second-period MEP and SEP recordings will be obtained under ciprofol-based anesthesia.
Remifentanil analgesia and standard physiologic targets will be maintained as consistently as clinically feasible across both periods.
|
Ciprofol will be administered intravenously for induction and/or maintenance according to the institutional anesthesia protocol and product labeling.
A suggested maintenance range is approximately 0.8 to 1.5 mg/kg/h, adjusted according to anesthetic depth, hemodynamics, surgical conditions, and patient safety.
Remimazolam will be administered intravenously for induction and/or maintenance according to the institutional anesthesia protocol and product labeling.
A suggested maintenance range is approximately 0.5 to 2 mg/kg/h or 1 to 2 mg/kg/h, adjusted according to anesthetic depth, hemodynamics, surgical conditions, body movement, and patient safety.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Within-participant difference in lower-extremity MEP peak-to-peak amplitude between ciprofol and remimazolam periods
기간: 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.
|
During surgery, at predefined stable monitoring windows under each study drug; up to 6 hours
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Within-participant difference in lower-extremity SEP amplitude
기간: During surgery, at predefined stable monitoring windows under each study drug; up to 6 hours
|
Lower-extremity somatosensory evoked potential amplitudes will be compared between the ciprofol and remimazolam periods.
|
During surgery, at predefined stable monitoring windows under each study drug; up to 6 hours
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 1일
기본 완료 (추정된)
2026년 12월 1일
연구 완료 (추정된)
2027년 1월 1일
연구 등록 날짜
최초 제출
2026년 7월 17일
QC 기준을 충족하는 최초 제출
2026년 7월 17일
처음 게시됨 (실제)
2026년 7월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 17일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026-KT253
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Ciprofol에 대한 임상 시험
-
Feng GaoSichuan Provincial People's Hospital아직 모집하지 않음
-
Northern Jiangsu People's Hospital모집하지 않고 적극적으로