Ciprofol and Remimazolam for Intraoperative Neurophysiological Monitoring During Spine Surgery (CIRIONM)
2026年7月17日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
60
段階
- フェーズ 4
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Within-participant difference in lower-extremity MEP peak-to-peak amplitude between ciprofol and remimazolam periods
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Within-participant difference in lower-extremity SEP amplitude
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月1日
一次修了 (推定)
2026年12月1日
研究の完了 (推定)
2027年1月1日
試験登録日
最初に提出
2026年7月17日
QC基準を満たした最初の提出物
2026年7月17日
最初の投稿 (実際)
2026年7月21日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月21日
QC基準を満たした最後の更新が送信されました
2026年7月17日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2026-KT253
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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Ciprofolの臨床試験
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