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

NCT07627750 | Not Yet Recruiting

• 3 other identifiers: HMU-BMH-ROC-IONM-2025-01225/BM-HDDD6513/QD-DHYHN
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Rocuronium; Motor Evoked Potentials; Somatosensory Evoked Potentials; Train-of-Four Ratio; Spine Surgery; Intraoperative Neurophysiological Monitoring; Total Intravenous Anesthesia

Outcome Measures

Primary Outcomes (1)

• Mean Intraoperative Motor Evoked Potential Amplitude

  Mean intraoperative motor evoked potential amplitude, measured in microvolts, recorded from predefined target muscles during spine surgery. The mean of three consecutive technically acceptable responses will be used at standardized intraoperative time points after stabilization of anesthesia and physiologic parameters.

  From baseline intraoperative neurophysiological monitoring after patient positioning to the final intraoperative neurophysiological monitoring recording before wound closure

Secondary Outcomes (9)

• Successful Motor Evoked Potential Recording

  During surgery

• Motor Evoked Potential Warning Events

  During surgery

• Surgical Field Condition

  During surgery

• Unwanted Patient Movement

  During surgery

• Time to Extubation

  From discontinuation of maintenance anesthesia to tracheal extubation

Study Arms (2)

Low-Dose Rocuronium Maintenance

EXPERIMENTAL

Participants in this group will receive rocuronium for tracheal intubation followed by low-dose rocuronium maintenance during surgery. Rocuronium will be titrated using quantitative train-of-four monitoring to maintain a train-of-four ratio from 0.60 to less than 0.90. All participants will receive standardized total intravenous anesthesia and intraoperative neurophysiological monitoring.

Drug: Low-Dose Rocuronium Maintenance

No Rocuronium Maintenance After Induction

ACTIVE COMPARATOR

Participants in this group will receive rocuronium for tracheal intubation only. No maintenance rocuronium will be administered after induction. Additional rocuronium may be given only as predefined safety rescue if clinically necessary. All participants will receive standardized total intravenous anesthesia and intraoperative neurophysiological monitoring.

Drug: Rocuronium

Interventions

Low-Dose Rocuronium Maintenance DRUG

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.

Low-Dose Rocuronium Maintenance

Rocuronium DRUG

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.

Also known as: Rocuronium for Intubation Only

No Rocuronium Maintenance After Induction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Pre-existing central or peripheral neurological disease that may affect intraoperative neurophysiological monitoring, such as quadriplegia, persistent sensory disorder, sequelae of stroke, or polyneuropathy.
• \. 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.
• \. Decompensated cardiovascular disease or severe respiratory disease that may affect emergence or anesthetic drug metabolism.
• \. Contraindication to intraoperative neurophysiological monitoring. 6. Contraindication to rocuronium. 7. Refusal to participate or withdrawal of consent at any time..

Sponsors & Collaborators

• Bach Mai Hospital: lead
• Hanoi Medical University: collaborator

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Toan Thang Nguyen, MD, PhD, Associate Professor

  Hanoi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Duc Minh Tran, MD

CONTACT

84869319291; tdminh1312@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The anesthesia team will not be masked because they administer and titrate rocuronium according to group assignment. The intraoperative neurophysiological monitoring assessor and the data analyst will be masked to group allocation when feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized in a 1:1 ratio to one of two parallel groups: low-dose rocuronium maintenance targeting a train-of-four ratio of 0.60 to less than 0.90, or no rocuronium maintenance after induction.

Study Record Dates

• First Submitted: May 30, 2026
• First Posted: June 4, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share