- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07525323
EMG ss AMG In Robotic/Laparoscopic Surgery (PEARL)
May 5, 2026 updated by: J. Ross Renew, M.D., Mayo Clinic
The Impact Of Electromyography Vs Acceleromyography On The Management Of Neuromuscular Block During Robotic And Laparoscopic Surgery: A Randomized Controlled Trial
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
400
Phase
- 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
-
-
Florida
-
Jacksonville, Florida, United States, 32224
- Mayo Clinic in Florida
-
-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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).
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AMG
The anesthesia team will manage the level of block based on AMG values
|
The anesthesia team will use an AMG device to monitor neuromuscular block
|
|
Active Comparator: EMG
The anesthesia team will manage the level of block based on EMG values
|
The anesthesia team will use an EMG device to monitor neuromuscular block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cumulative rocuronium dose
Time Frame: Perioperative/Periprocedural
|
Weight- and time-adjusted mean cumulative rocuronium dose between the AMG and EMG groups
|
Perioperative/Periprocedural
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean sugammadex dose
Time Frame: Perioperative/Periprocedural
|
Mean sugammadex dose between the two groups
|
Perioperative/Periprocedural
|
|
Number of rocuronium administrations
Time Frame: Perioperative/Periprocedural
|
Number of rocuronium administrations throughout the case,
|
Perioperative/Periprocedural
|
|
Frequency of placing a peripheral nerve stimulator
Time Frame: Perioperative/Periprocedural
|
Frequency of placing a peripheral nerve stimulator
|
Perioperative/Periprocedural
|
|
Depth of neuromuscular block prior to sugammadex administration
Time Frame: Perioperative/Periprocedural
|
Depth of neuromuscular block prior to sugammadex administration
|
Perioperative/Periprocedural
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Johnathan Renew, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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 (Estimated)
May 31, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
March 30, 2026
First Submitted That Met QC Criteria
April 6, 2026
First Posted (Actual)
April 13, 2026
Study Record Updates
Last Update Posted (Actual)
May 6, 2026
Last Update Submitted That Met QC Criteria
May 5, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 25-014604
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
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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