Spine SurgeryROC-IONMNCT07627750
Low-Dose Rocuronium Maintenance During Spine Surgery With Intraoperative Neurophysiological Monitoring
A study testing Low-Dose Rocuronium Maintenance and Rocuronium in people with Spine Surgery and Intraoperative Neurophysiological Monitoring, run by Bach Mai Hospital at 1 site in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Surgery, Intraoperative Neurophysiological Monitoring, Neuromuscular Blockade
- What is being tested?
- Low-Dose Rocuronium Maintenance and Rocuronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteVietnam
- Study dates
- 7 Oct 2026to Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older.
- Patients scheduled for spine surgery under general anesthesia.
- 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.
Who cannot join
- 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.
- 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.
- Contraindication to rocuronium.
- Refusal to participate or withdrawal of consent at any time.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Bach Mai Hospital
Hanoi, Hanoi, 100000
Duc Minh Tran, MD, +84869319291, tdminh1312@gmail.com
About this study
Official title: 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
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.
Read the detailed description
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.
- Being tested
- Low-Dose Rocuronium Maintenance, Rocuronium
- Keywords
- Rocuronium, Motor Evoked Potentials, Somatosensory Evoked Potentials, Train-of-Four Ratio, Spine Surgery, Intraoperative Neurophysiological Monitoring, Total Intravenous Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Dose Rocuronium MaintenanceDrug
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.
RocuroniumDrug
Also called Rocuronium for Intubation Only
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Proportion of participants with successful intraoperative motor evoked potential recording from at least one predefined target muscle.
Measured: During surgery
Motor Evoked Potential Warning Events
Number of intraoperative motor evoked potential warning events, defined as a decrease of 50 percent or more in amplitude from baseline lasting more than 5 minutes and not attributable to surgical manipulation after correction of physiologic and technical factors.
Measured: During surgery
Surgical Field Condition
Surgical field condition assessed using the Leiden-Surgical Rating Scale, ranging from 1 to 5, with higher scores indicating better surgical conditions.
Measured: During surgery
Unwanted Patient Movement
Occurrence and number of unwanted patient movement events that affect surgical manipulation or require anesthetic or neuromuscular blockade adjustment.
Measured: During surgery
Time to Extubation
Time from discontinuation of maintenance anesthetic infusion to safe tracheal extubation, measured in minutes.
Measured: From discontinuation of maintenance anesthesia to tracheal extubation
New Postoperative Neurological Deficit
Occurrence of new postoperative motor or sensory neurological deficit assessed in the post-anesthesia care unit and within 24 to 48 hours after surgery.
Measured: Post-anesthesia care unit and 24 to 48 hours after surgery
Somatosensory Evoked Potential Stability
Proportion of intraoperative monitoring time without significant somatosensory evoked potential changes, defined as latency increase of 10 percent or more or amplitude decrease of 50 percent or more from baseline lasting more than 5 minutes and not attributable to surgical manipulation.
Measured: During surgery
Time to Emergence
Time from discontinuation of maintenance anesthetic infusion to eye opening on verbal command, measured in minutes.
Measured: From discontinuation of maintenance anesthesia to eye opening on verbal command
Early Postoperative Respiratory Events
Occurrence of early respiratory events, including oxygen desaturation below 92 percent, laryngospasm, bronchospasm, sputum obstruction, or delayed extubation due to respiratory muscle weakness.
Measured: During emergence and within 60 minutes after arrival in the post-anesthesia care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start7 Oct 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bach Mai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hanoi Medical University
- Responsible party
- Principal investigator, Nguyen Toan Thang, Hanoi Medical University
- Investigators
- Toan Thang Nguyen, MD, PhD, Associate Professor, Principal investigator, Hanoi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627750
- Sponsor's protocol ID
- HMU-BMH-ROC-IONM-2025-01
- Other IDs
- 225/BM-HDDD, 6513/QD-DHYHN
- Acronym
- ROC-IONM
- Status last verified
- Oct 2026
- First submitted
- 30 May 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared because the study involves sensitive clinical and perioperative data. Data are protected by privacy and ethical restrictions. De-identified aggregate data may be available from the corresponding author upon reasonable request and with approval from the relevant ethics committee.