The Effect of Sugammadex During Transcranial Electrical M... | NCT04471376

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

NCT04471376

Sponsor

Beijing Tiantan Hospital

Status

Completed

Last Update Posted

Apr 6, 2021Actual

Enrollment

66Actual

Phase

Not Applicable

Conditions

Sugammadex

Interventions

Sugammadex

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 16, 2020Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Jul 10, 2020

First Submission Date that Met QC Criteria

Jul 10, 2020

First Posted Date

Jul 15, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2021

Last Update Posted Date

Apr 6, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sugammadex group	Active Comparator		Drug: Sugammadex
control group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sugammadex	Drug	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The amplitude of MEP	mean value of amplitudes of TceMEPs in abductor pollicis brevis muscles of both upper extremities	5 minutes after dura opening

Secondary Outcomes

Measure	Description	Time Frame
The amplitude of MEP	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ruquan Han, M.D., Ph.D	Department of Anesthesiology, Beijing Tiantan Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Tiantan Hospital		Beijing		100070	China

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

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

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.

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077122	Sugammadex

Ancestor Terms

ID	Term
D047408	gamma-Cyclodextrins
D003505	Cyclodextrins
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds

Browse Leaves

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Browse Branches

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