Low-Dose Rocuronium Maintenance During Spine Surgery With Intraoperative Neurophysiological Monitoring

Официальное название

A Randomized Controlled Trial Comparing Low-Dose Rocuronium Maintenance Versus Discontinuation After Induction on Motor Evoked Potential Quality During Spine Surgery With Intraoperative Neurophysiological Monitoring

Обзор

This randomized controlled trial will compare two strategies for rocuronium use during general anesthesia for spine surgery with intraoperative neurophysiological monitoring. Participants undergoing spine surgery under general anesthesia with motor evoked potential and/or somatosensory evoked potential monitoring will be randomized to either low-dose rocuronium maintenance targeting a train-of-four ratio of 0.60 to less than 0.90, or no rocuronium maintenance after induction. The main objective is to compare the effects of these two strategies on the quality of intraoperative neurophysiological monitoring, especially motor evoked potential signals. Secondary objectives include comparing surgical field conditions, unwanted patient movement, emergence and extubation times, early respiratory events, and new postoperative neurological deficits. The study will be conducted at the Center for Anesthesia and Surgical Intensive Care, Bach Mai Hospital, Hanoi, Vietnam. The planned sample size is 62 participants, with 31 participants in each group.

Подробное описание

Intraoperative neurophysiological monitoring is commonly used during complex spine surgery to help detect early neurological injury. Motor evoked potentials are particularly sensitive to neuromuscular blockade. Avoiding maintenance neuromuscular blockade may improve motor evoked potential signal quality, but may increase the risk of unwanted patient movement and suboptimal surgical field conditions. Conversely, low-dose rocuronium maintenance may improve surgical conditions, but may reduce motor evoked potential amplitude if neuromuscular blockade is excessive.

This trial will evaluate whether low-dose rocuronium maintenance, titrated by quantitative neuromuscular monitoring, can preserve intraoperative neurophysiological monitoring quality while improving surgical field conditions compared with discontinuation of rocuronium after induction.

All participants will receive standardized total intravenous anesthesia with propofol-based maintenance, bispectral index monitoring, quantitative train-of-four monitoring, and intraoperative neurophysiological monitoring. Rocuronium will be administered for tracheal intubation in both groups. In the low-dose maintenance group, rocuronium will be titrated to maintain a train-of-four ratio from 0.60 to less than 0.90. In the no-maintenance group, no additional rocuronium will be given after induction unless predefined safety rescue is required.

The primary outcome will be intraoperative motor evoked potential signal quality, including mean motor evoked potential amplitude. Secondary outcomes will include successful motor evoked potential recording, motor evoked potential warning events, somatosensory evoked potential stability, surgical field condition, unwanted patient movement, time to emergence, time to extubation, early postoperative respiratory events, and new postoperative neurological deficits.

Вмешательства

• Препарат Low-Dose Rocuronium Maintenance
  Rocuronium will be administered for tracheal intubation and then maintained at a low dose during surgery. The infusion will be titrated according to quantitative train-of-four monitoring to maintain a train-of-four ratio from 0.60 to less than 0.90.
• Препарат Rocuronium
  Rocuronium will be administered only for tracheal intubation during induction of anesthesia. No maintenance rocuronium will be administered after induction, except for predefined safety rescue if clinically necessary.

Первичные конечные точки

• Mean Intraoperative Motor Evoked Potential Amplitude [Срок оценки: From baseline intraoperative neurophysiological monitoring after patient positioning to the final intraoperative neurophysiological monitoring recording before wound closure]

Вторичные конечные точки (9)

• Successful Motor Evoked Potential Recording [Срок оценки: During surgery]
• Motor Evoked Potential Warning Events [Срок оценки: During surgery]
• Surgical Field Condition [Срок оценки: During surgery]
• Unwanted Patient Movement [Срок оценки: During surgery]
• Time to Extubation [Срок оценки: From discontinuation of maintenance anesthesia to tracheal extubation]
• New Postoperative Neurological Deficit [Срок оценки: Post-anesthesia care unit and 24 to 48 hours after surgery]
• Somatosensory Evoked Potential Stability [Срок оценки: During surgery]
• Time to Emergence [Срок оценки: From discontinuation of maintenance anesthesia to eye opening on verbal command]
• Early Postoperative Respiratory Events [Срок оценки: During emergence and within 60 minutes after arrival in the post-anesthesia care unit]

Критерии участия

Критерии включения

\- 1. Patients aged 18 years or older. 2. Patients scheduled for spine surgery under general anesthesia. 3. Patients undergoing spine surgery with intraoperative neurophysiological monitoring, including motor evoked potentials and/or somatosensory evoked potentials.

4\. Patients who agree to participate in the study and provide written informed consent.

Критерии исключения

• 1\. Pre-existing central or peripheral neurological disease that may affect intraoperative neurophysiological monitoring, such as quadriplegia, persistent sensory disorder, sequelae of stroke, or polyneuropathy.

2\. History of epilepsy or electroencephalographic disorder. 3. Use of neuropsychiatric drugs, strong sedatives, or drugs affecting neuromuscular or neurological conduction within 48 hours before surgery.

4\. Decompensated cardiovascular disease or severe respiratory disease that may affect emergence or anesthetic drug metabolism.

5\. Contraindication to intraoperative neurophysiological monitoring. 6. Contraindication to rocuronium. 7. Refusal to participate or withdrawal of consent at any time..

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07627750 · HMU-BMH-ROC-IONM-2025-01 · 225/BM-HDDD · 6513/QD-DHYHN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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