The Effect of Sugammadex During Transcranial Electrical Motor Evoked Potential Monitoring in Spinal Surgery

April 5, 2021 updated by: Ruquan Han, Beijing Tiantan Hospital

Intraoperative Reversal of Muscle Relaxants During Transcranial Electrical Motor Evoked Potential Monitoring in Patients Undergoing Spinal Surgery

Transcranial motor evoked potential (TcMEP) monitoring is conventionally performed during neurosurgical procedures without or with minimal neuromuscular blockade (NMB) because of its potential interference with signal interpretation. However, full blockade offers increased anesthetic management options and facilitates surgery. Here, investigators want to assess the effect of Sugammadex during TcMEP in adult patients. Sugammadex is designed to encapsulate rocuronium and reverse rocuronium-induced neuromuscular blockade. 64 patients undergoing thoracic or lumbar spinal surgery will be randomly allocated into sugammadex group or control group under a ratio of 1 to 1. Patients will receive either continuous infusion of rocuronium to produce blockade maintained at least two twitches in Train-of-Four (TOF), rocuronium infusion will be discontinued and 2 mg/kg of sugammadex will be infused while dura opening in sugammadex group. Whereas no muscle relaxant will be given after anesthetic induction in control group. The primary aim of this study is to compare mean value of amplitudes of TcMEPs in abductor pollicis brevis muscles of both upper extremities 5 minutes after dura opening.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100070
        • Beijing Tiantan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-65 years
  • ASA status I-II
  • Patients undergo thoracic or lumbar spinal surgery
  • tcMEP monitoring during the surgery
  • Informed consent signed by patients

Exclusion Criteria:

  • BMI ≥35 Kg/m-2
  • history of epilepsy or use of antiepileptic drugs, neuromuscular disorder(s)
  • history or family history of malignant hyperthermia
  • allergies to sugammadex, NMBs or other medication(s) used during general anesthesia
  • anemia, hemoglobin <110g/L,
  • TcMEPs stimulate or record site infection
  • preoperative neurological dysfunction in both upper extremities
  • cardiac pacemaker
  • pregnancy and breast-feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: control group
ACTIVE_COMPARATOR: Sugammadex group
Drug: Sugammadex
Sugammadex group received a rocuronium infusion producing blockade by qualitative train-of-four ≥2 at the ulnar nerve. 2 mg/kg of Sugammadex will be infused when conducting TcMEP
Other Names:
  • Bridion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The amplitude of MEP
Time Frame: 5 minutes after dura opening
mean value of amplitudes of TceMEPs in abductor pollicis brevis muscles of both upper extremities
5 minutes after dura opening

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The amplitude of MEP
Time Frame: 10, 20, 30 and 60 minutes after dura opening
Mean value of amplitudes of TceMEPs in abductor pollicis brevis muscles of both upper extremities 10, 20, 30 and 60 minutes after dura opening.
10, 20, 30 and 60 minutes after dura opening
The latencies of MEPs
Time Frame: 5, 10, 20, 30 and 60 minutes after dura opening.
Mean value of latencies of TceMEPs in abductor pollicis brevis muscles of both upper extremities
5, 10, 20, 30 and 60 minutes after dura opening.
Respiratory parameters
Time Frame: during the surgery
Peak respiratory pressures and incidence of peak insufflation pressure of more than 25cmH2O.
during the surgery
Adverse effects of sugammadex
Time Frame: during and 24 hours after the surgery
Anaphylaxis, arrhythmias, post-procedure pain, nausea and vomiting, fever and diarrhea, etc.
during and 24 hours after the surgery
Incidence of body movement
Time Frame: during the surgery
either nociception-induced movement (defined as "coughing" or reflexive limb movement temporally related to MEP stimulation) or excessive field movement (defined as grossly visible movement as determined by surgical and anesthesia teams).
during the surgery
Recurrence of neuromuscular blockade
Time Frame: At the end of surgery
Recurrence of neuromuscular blockade at the end of surgery.
At the end of surgery
Motor function assessment
Time Frame: 5 days after surgery
SMP-a scale
5 days after surgery
Total bleeding volume
Time Frame: during the surgery
Total bleeding volume during the surgery
during the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 16, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WJP20200708

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study protocol, statistical analysis plan and informed consent form will be shared beginning 3 months and ending 5 years following 5 years article publication.

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following 5 years article publication

IPD Sharing Access Criteria

Proposals should be directed to ruquan.han@ccmu.edu.cn. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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