EMG ss AMG In Robotic/Laparoscopic Surgery (PEARL)
The Impact Of Electromyography Vs Acceleromyography On The Management Of Neuromuscular Block During Robotic And Laparoscopic Surgery: A Randomized Controlled Trial
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32224
- Mayo Clinic in Florida
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
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
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Johnathan Renew, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- 25-014604
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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