EMG ss AMG In Robotic/Laparoscopic Surgery | NCT07525323

Studies
EMG ss AMG In Robotic/Laparoscopic Surgery

NCT07525323

Sponsor

Mayo Clinic

Status

Enrolling by invitation

Last Update Posted

May 6, 2026Actual

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Surgery

Interventions

AMG device
EMG

Countries

United States

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

May 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 31, 2026Estimated

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Mar 30, 2026

First Submission Date that Met QC Criteria

Apr 6, 2026

First Posted Date

Apr 13, 2026Actual

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

May 5, 2026

Last Update Posted Date

May 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to compare the mean cumulative weight-based/time-corrected rocuronium dose administered in patients undergoing robotic- or laparoscopic- assisted surgery using either acceleromyography or electromyography.

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

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AMG	Experimental	The anesthesia team will manage the level of block based on AMG values	Device: AMG device
EMG	Active Comparator	The anesthesia team will manage the level of block based on EMG values	Device: EMG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AMG device	Device	The anesthesia team will use an AMG device to monitor neuromuscular block	AMG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cumulative rocuronium dose	Weight- and time-adjusted mean cumulative rocuronium dose between the AMG and EMG groups	Perioperative/Periprocedural

Secondary Outcomes

Measure	Description	Time Frame
Mean sugammadex dose	Mean sugammadex dose between the two groups	Perioperative/Periprocedural
Number of rocuronium administrations	Number of rocuronium administrations throughout the case,

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Age > or = 18 years old
Patients willing to participate and provide an integrated, informed consent
Patients undergoing elective laparoscopic- or robotic-assisted surgical procedures
Anticipated surgery duration < 300 minutes Exclusion Criteria
Patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
Patients with systemic neuromuscular diseases such as myasthenia gravis.
Patients having surgery that would involve prepping the arm into the sterile field.
Patients with chronic kidney disease (eGFR <60).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Johnathan Renew	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Florida		Jacksonville	Florida	32224	United States

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided