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Ciprofol and Remimazolam for Intraoperative Neurophysiological Monitoring During Spine Surgery (CIRIONM)

17 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • Fase 4

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  1. Age 18 to 75 years.
  2. Scheduled to undergo elective spine surgery.
  3. Planned intraoperative monitoring with MEP and SEP/SSEP.
  4. Expected surgical duration sufficient to complete two study drug periods and intraoperative monitoring windows, preferably at least 3.5 to 4 hours.
  5. American Society of Anesthesiologists physical status I to III.
  6. Able to provide written informed consent, or consent provided by a legally authorized representative where applicable.

Exclusion Criteria:

  1. Known allergy or contraindication to ciprofol, remimazolam, benzodiazepines, propofol-related formulations, opioids, or relevant excipients.
  2. Severe preoperative motor or sensory deficit preventing interpretable target MEP or SEP baseline recordings.
  3. Implanted cardiac pacemaker, skull defect, or other condition considered unsuitable for transcranial electrical stimulation.
  4. Severe neuromuscular disease, poorly controlled epilepsy, severe cognitive impairment, or inability to complete postoperative neurological assessment.
  5. Severe hepatic or renal dysfunction, severe hemodynamic instability, shock, or requirement for high-dose vasoactive medications before enrollment.
  6. Long-term benzodiazepine, sedative-hypnotic, antiepileptic drug use, or drug/alcohol dependence that may substantially alter anesthetic response.
  7. Expected need for continuous deep neuromuscular blockade during surgery, preventing valid MEP monitoring.
  8. Any other condition judged by the investigators to make participation unsuitable or unsafe.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Droga: Ciprofol
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.
Droga: Remimazolam
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.
Experimental: 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.
Droga: Ciprofol
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.
Droga: Remimazolam
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Within-participant difference in lower-extremity MEP peak-to-peak amplitude between ciprofol and remimazolam periods
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Within-participant difference in lower-extremity SEP amplitude
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Affiliated 2 Hospital of Nantong University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de agosto de 2026

Finalización primaria (Estimado)

1 de diciembre de 2026

Finalización del estudio (Estimado)

1 de enero de 2027

Fechas de registro del estudio

Enviado por primera vez

17 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

17 de julio de 2026

Publicado por primera vez (Actual)

21 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2026-KT253

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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