Low-Dose Rocuronium Maintenance During Spine Surgery With Intraoperative Neurophysiological Monitoring
NCT07627750 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62
Last updated 2026-06-04
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.
Conditions
- Spine Surgery
- Intraoperative Neurophysiological Monitoring
- Neuromuscular Blockade
Interventions
- DRUG
-
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.
- DRUG
-
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.
Sponsors & Collaborators
-
Hanoi Medical University
collaborator OTHER -
Bach Mai Hospital
lead OTHER
Principal Investigators
-
Toan Thang Nguyen, MD, PhD, Associate Professor · Hanoi Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2028-12-31
- Completion
- 2028-12-31
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