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

Not yet recruiting

• Conditions: Anesthesia; Neuromuscular Blockade
• Interventions: Device: EMG Assessement of Recovery of Neuromuscular Function

• Registration Number: NCT06467448
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

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 Timeline

• Status Verified: 2024-06
• Study Start: 2024-06
• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-14
• Last Update Submitted: 2024-06-14
• Study First Posted: 2024-06-21
• Last Update Posted: 2024-06-21
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adductor Pollicis EMG	EMG Assessement of Recovery of Neuromuscular Function	The Train of Four Ratio will be recorded at 90% as a time and as a reference point
Adductor Digiti Minimi	EMG Assessement of Recovery of Neuromuscular Function	The Train of Four Ratio will be recorded when the adductor pollicis ratio reads 90%

Primary Outcome Measures

Name	Time	Method
Difference in Measured Recovery of Train of Four at Adductor Pollicis and Adductor Digiti Minimi	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

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States