Back to resultsCardiac Output and Recovery Time
Primary Purpose
Residual Neuromuscular Blockade
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TetraGraph
Sponsored by
About this trial
This is an interventional other trial for Residual Neuromuscular Blockade focused on measuring Neuromuscular Blockade, Tetragraph, AMG, EMG
Eligibility Criteria
Inclusion Criteria:
- Age > or = 18 years old.
- Patients willing to participate and provide an informed consent.
- Patients undergoing an elective surgical procedure requiring administration of rocuronium, and the use of a pulmonary artery catheter intraoperatively.
Exclusion Criteria:
- Patients with unilateral disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture.
- Patients with systemic neuromuscular diseases such as myasthenia gravis.
- Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease.
- Patients having surgery that would involve prepping the arm or leg into the sterile field.
Sites / Locations
- Mayo Clinic in Florida
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TetraGraph monitoring
Arm Description
Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on either hand at a discretion of the anesthesiologist
Outcomes
Primary Outcome Measures
Recovery time after administration of sugammadex and its correlation to cardiac output measure
Change in cardiac output measurement after reversal with sugammadex as compared to the time it takes to recover from the rocuronium-induced blockade.
Secondary Outcome Measures
Correlation of speed of recovery from neuromuscular blockade and age.
Change in the speed of recovery from neuromuscular blockade as compared to participant's age.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04619225
Brief Title
Cardiac Output and Recovery Time
Official Title
Correlation Between Cardiac Output and Recovery Time After Reversal of Rocuronium-Induced Blockade With Sugammadex
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 14, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research is to determine the time it takes to reverse the effects of the intraoperative medication given to relax the muscles and how this period of recovery correlates with a function of the heart.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Residual Neuromuscular Blockade
Keywords
Neuromuscular Blockade, Tetragraph, AMG, EMG
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TetraGraph monitoring
Arm Type
Experimental
Arm Description
Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on either hand at a discretion of the anesthesiologist
Intervention Type
Device
Intervention Name(s)
TetraGraph
Intervention Description
FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes.
Primary Outcome Measure Information:
Title
Recovery time after administration of sugammadex and its correlation to cardiac output measure
Description
Change in cardiac output measurement after reversal with sugammadex as compared to the time it takes to recover from the rocuronium-induced blockade.
Time Frame
Up to 1 hour postoperative
Secondary Outcome Measure Information:
Title
Correlation of speed of recovery from neuromuscular blockade and age.
Description
Change in the speed of recovery from neuromuscular blockade as compared to participant's age.
Time Frame
Up to 1 hour postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > or = 18 years old.
Patients willing to participate and provide an informed consent.
Patients undergoing an elective surgical procedure requiring administration of rocuronium, and the use of a pulmonary artery catheter intraoperatively.
Exclusion Criteria:
Patients with unilateral disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture.
Patients with systemic neuromuscular diseases such as myasthenia gravis.
Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease.
Patients having surgery that would involve prepping the arm or leg into the sterile field.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J.Ross Renew, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32223
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Cardiac Output and Recovery Time
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