Comparing Train-of-Four Recovery in the Adductor Pollicis Versus the Adductor Digiti Minimi in Elective Surgery Patients

NCT06467448 | Completed FDA Device

• 1 other identifier: 24-1013
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Neuromuscular Blockade

Outcome Measures

Primary Outcomes (1)

• Difference in Measured Recovery of Train of Four at Adductor Pollicis and Adductor Digiti Minimi

  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

Study Arms (2)

Adductor Pollicis EMG

The Train of Four Ratio will be recorded at 90% as a time and as a reference point

Device: EMG Assessement of Recovery of Neuromuscular Function

Adductor Digiti Minimi

The Train of Four Ratio will be recorded when the adductor pollicis ratio reads 90%

Device: EMG Assessement of Recovery of Neuromuscular Function

Interventions

EMG Assessement of Recovery of Neuromuscular Function DEVICE

EMG Train of Four Assessment of Recovery of Neuromuscular Function

Adductor Digiti Minimi; Adductor Pollicis EMG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consented patients undergoing general anesthesia with an endotracheal tube and non depolarizing muscle relaxants and objective monitoring of train of four.

You may qualify if:

• Surgery and general anesthesia with administration of non depolarizing neuromuscular blocking drug

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Study Officials

• Stuart Grant

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 21, 2024
• Study Start: March 18, 2024
• Primary Completion: May 9, 2025
• Study Completion: June 1, 2025
• Last Updated: January 13, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)