Low-Dose Rocuronium Maintenance During Spine Surgery With Intraoperative Neurophysiological Monit… (NCT07627750) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Low-Dose Rocuronium Maintenance During Spine Surgery With Intraoperative Neurophysiological Monitoring
62 participantsStarted 2026-06
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
\- 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.
Exclusion Criteria:
* 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..
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Intraoperative Motor Evoked Potential Amplitude
Timeframe: From baseline intraoperative neurophysiological monitoring after patient positioning to the final intraoperative neurophysiological monitoring recording before wound closure