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

ConditionsSpine SurgeryIntraoperative Neurophysiological MonitoringNeuromuscular Blockade
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBach Mai Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Low-Dose Rocuronium MaintenanceExperimental treatment 1 intervention
Group B: No Rocuronium Maintenance After InductionActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Successful Motor Evoked Potential Recording

Proportion of participants with successful intraoperative motor evoked potential recording from at least one predefined target muscle.

Time frame
During surgery
2

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.

Time frame
During surgery
3

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.

Time frame
During surgery
4

Unwanted Patient Movement

Occurrence and number of unwanted patient movement events that affect surgical manipulation or require anesthetic or neuromuscular blockade adjustment.

Time frame
During surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bach Mai Hospital

Lead sponsor

Hanoi Medical University

Sponsor institution

Hanoi Medical University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: