Intraoperative Neurophysiological MonitoringPhase 4CIRIONMNCT07718152
Ciprofol and Remimazolam for Intraoperative Neurophysiological Monitoring During Spine Surgery
A Phase 4 study testing Ciprofol and Remimazolam in people with Intraoperative Neurophysiological Monitoring and Spine Surgery, run by Affiliated 2 Hospital of Nantong University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intraoperative Neurophysiological Monitoring, Spine Surgery, Anesthesia
- What is being tested?
- Ciprofol and Remimazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Ciprofol, Remimazolam
- Keywords
- Ciprofol, Remimazolam, Motor evoked potential, Somatosensory evoked potential, Intraoperative neurophysiological monitoring, Spine surgery, Total intravenous anesthesia, Crossover trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofolDrug
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.
RemimazolamDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Ciprofol-Remimazolam Sequence | Experimental | 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. Receives: Drug: Ciprofol; Drug: Remimazolam |
| Remimazolam-Ciprofol Sequence | Experimental | 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. Receives: Drug: Ciprofol; Drug: Remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-participant difference in lower-extremity MEP peak-to-peak amplitude between ciprofol and remimazolam periods
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.
Measured: During surgery, at predefined stable monitoring windows under each study drug; up to 6 hours
Secondary outcomes (1)
Within-participant difference in lower-extremity SEP amplitude
Lower-extremity somatosensory evoked potential amplitudes will be compared between the ciprofol and remimazolam periods.
Measured: During surgery, at predefined stable monitoring windows under each study drug; up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Neurophysiological MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized in a 1:1 ratio to one of two two-period sequences. In the CR sequence, ciprofol will be used during the first stable intraoperative monitoring period and then switched to remimazolam for the second period. In the RC sequence, remimazolam will be used first and then switched to ciprofol. A stabilization and washout period of approximately 45 to 60 minutes will be used after drug transition before the second monitoring window whenever surgical conditions allow.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated 2 Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiawei Jiang, Affiliated 2 Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718152
- Sponsor's protocol ID
- 2026-KT253
- Acronym
- CIRIONM
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Alternating Ciprofol and Remimazolam on Intraoperative Motor and Somatosensory Evoked Potentials During Spine Surgery: A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT07718152
- Acronym / sponsor ID
- CIRIONM / 2026-KT253
- Keywords
- Ciprofol, Remimazolam, Motor evoked potential, Somatosensory evoked potential, Intraoperative neurophysiological monitoring, Spine surgery, Total intravenous anesthesia, Crossover trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Affiliated 2 Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to one of two two-period sequences. In the CR sequence, ciprofol will be used during the first stable intraoperative monitoring period and then switched to remimazolam for the second period. In the RC sequence, remimazolam will be used first and then switched to ciprofol. A stabilization and washout period of approximately 45 to 60 minutes will be used after drug transition before the second monitoring window whenever surgical conditions allow.
| Arm | Type | Receives |
|---|---|---|
| Ciprofol-Remimazolam Sequence | Experimental | Drug: Ciprofol, Drug: RemimazolamParticipants 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. |
| Remimazolam-Ciprofol Sequence | Experimental | Drug: Ciprofol, Drug: RemimazolamParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiprofolCiprofol 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. | Drug | Ciprofol-Remimazolam Sequence, Remimazolam-Ciprofol Sequence |
| RemimazolamRemimazolam 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. | Drug | Ciprofol-Remimazolam Sequence, Remimazolam-Ciprofol Sequence |
Primary outcome
Within-participant difference in lower-extremity MEP peak-to-peak amplitude between ciprofol and remimazolam periods
Time frame: 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.
1 secondary outcome
Within-participant difference in lower-extremity SEP amplitude
Time frame: During surgery, at predefined stable monitoring windows under each study drug; up to 6 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ciprofol and Remimazolam in people with Intraoperative Neurophysiological Monitoring and Spine Surgery, run by Affiliated 2 Hospital of Nantong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Within-participant difference in lower-extremity MEP peak-to-peak amplitude between ciprofol and remimazolam periods (time frame: During surgery, at predefined stable monitoring windows under each study drug; up to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.