- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06467448
Comparing Train-of-Four Recovery in the Adductor Pollicis Versus the Adductor Digiti Minimi in Elective Surgery Patients
Comparing Train-of-Four Recovery in the Adductor Pollicis Versus the Adductor Digiti Minimi in Elective Surgery Patients Using EMG
The train-of-four (TOF) ratio is a quantitative measure used in anesthesia to assess the degree of neuromuscular blockade induced by neuromuscular blocking agents during surgical procedures. Current American Society of Anesthesiologists guidelines recommend monitoring the TOF ratio to guide the administration and reversal of NMBAs, with a target ratio of 0.9 or higher at adductor pollicis muscle indicating adequate reversal and restoration of neuromuscular function.
This proposed study aims to observe and compare the TOF ratio between two different muscles of the hand: adductor pollicis and adductor digiti minim using anesthesia monitors on both of their arms during recovery of neuromuscular function. Surgery and anesthesia will occur per standard of care.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study population will enroll adult patients (>18) who will receive non-depolarizing neuromuscular blocking drugs as part of a routine general anesthetic and who will have monitoring of their recovery from neuromuscular block performed using the Tetragraph (Senzime Sweden). Patients with upper limb weakness, neurological deficits, and inability to use the other arm to record the second EMG recording will be excluded.
Procedures (methods):
Adult patients undergoing general anesthesia with the use of muscle relaxants will have anesthesia monitors on both of their arms. On one arm, the study sticky pad will be placed on the forearm and over the base of the little finger. On the other arm, the standard monitor is placed on the forearm and over the base of the thumb.
To identify pre-operative patients, an EPIC report will be utilized to screen for eligible participants. Patients will be contacted via phone by a research team member the day before their procedure and enrolled. Informed consent will be formally obtained on the day of the procedure.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Surgery and general anesthesia with administration of non depolarizing neuromuscular blocking drug
Exclusion Criteria:
- neuromuscular disease or weakness of one of upper limbs.
- Inability to use one of subjects arms to record neuromuscular monitor.
- Contraindication to administration or allergy to non depolarizing neuromuscular blocking drug.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adductor Pollicis EMG
The Train of Four Ratio will be recorded at 90% as a time and as a reference point
|
EMG Train of Four Assessment of Recovery of Neuromuscular Function
|
|
Adductor Digiti Minimi
The Train of Four Ratio will be recorded when the adductor pollicis ratio reads 90%
|
EMG Train of Four Assessment of Recovery of Neuromuscular Function
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in Measured Recovery of Train of Four at Adductor Pollicis and Adductor Digiti Minimi
Time Frame: All assessments are intraoperative and complete in one day
|
The train of four ratio at the digiti minimi will be recorded when the adductor pollicis ratio reads 90 percent
|
All assessments are intraoperative and complete in one day
|
Collaborators and Investigators
Investigators
- Principal Investigator: Stuart Grant, University of North Carolina, Chapel Hill
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 24-1013
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.
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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