Median Versus Ulnar Nerve Quantitative Electromyography Neuromuscular Blockade Monitoring Comparison

NCT06553131 | Recruiting FDA Device

• 1 other identifier: IRB 5240163
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Medications used to relax the muscles are used during surgery. The amount of muscle relaxation can monitored with devices that stimulate a specific nerve and evaluate the muscle response. The response to, and recovery from, medications that relax the muscles are best described for a nerve in the arm called the ulnar nerve. The investigators believe that other nerves in the arm, such as the median nerve, could be used to monitor the amount of muscle relaxation. The purpose of this study is to compare the muscle response at two different nerve sites after giving medications to relax the muscles. This study is going to measure the depth of muscle relaxation during surgery at two different sites. The muscle response to stimulation of the ulnar nerve (located in the arm) will be compared to the muscle response to stimulation of the median nerve (also located in the arm).

Conditions

Neuromuscular Blockade

Keywords

Median Nerve; Neuromuscular Blockade; Ulnar Nerve

Outcome Measures

Primary Outcomes (1)

• Neuromuscular transmission nerve monitoring concordance

  The length of time between rocuronium administration and first post-tetanic twitch for both nerves

  Change in time between administration of rocuronium at beginning of surgery and the appearance of one post-tetanic twitch on a monitor, typically 20 minutes after sedation

Secondary Outcomes (3)

• Non-inferiority of median nerve neuromuscular monitoring compared to ulnar nerve neuromuscular monitoring - first train of four

  Change in time between administration of rocuronium at beginning of surgery and the appearance of the first Train-of-Four twitch on a monitor, typically 30 minutes after appearance of post-tetanic twitch

• Non-inferiority of median nerve neuromuscular monitoring compared to ulnar nerve neuromuscular monitoring - second train of four

  Change in time between administration of rocuronium at beginning of surgery and the appearance of the first instance of 2 Train-of-Four twitches on a monitor, typically 30 minutes after appearance of first train-of-four twitch

• Non-inferiority of median nerve neuromuscular monitoring compared to ulnar nerve neuromuscular monitoring - reversal

  Change in time between administration of sugammadex at end of surgery and the appearance of a Train-of-Four ratio greater than or equal to 0.9 on a monitor, typically 5 minutes after sugammadex administration

Study Arms (1)

Surgical Patients Receiving Non-Depolarizing Neuromuscular Blockade

Surgical patients having surgery that requires muscle relaxation with non-depolarizing neuromuscular blockers and monitoring of the depth of muscle blockade.The muscle response to nerve stimulation will be compared between the ulnar and median nerve.

Device: Neuromuscular Transmission Monitoring

Interventions

Neuromuscular Transmission Monitoring DEVICE

A neuromuscular transmission module connected to electrodes applied to the skin and positioned to provide stimulation of a single nerve and monitor the muscular response to nerve stimulation

Surgical Patients Receiving Non-Depolarizing Neuromuscular Blockade

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for elective surgery at Loma Linda University Medical Center

You may qualify if:

• Adults 18 - 75 years of age who are able to provide consent
• Scheduled for elective surgery requiring muscle relaxation, in a supine position under general anesthesia, with an anticipated duration of at least 1.5 hours

You may not qualify if:

• Contraindication to rocuronium use
• Comorbidities that may prolong the duration of neuromuscular blockade or alter pharmacodynamics and/or pharmacokinetics, such as:
• Neuromuscular disease
• Expected or known difficult airway
• Rocuronium allergy
• BMI \< 18.5 or \> 40
• History of adhesive allergy
• Upper extremity weakness, limb deformity, or absence of all or part of an upper limb
• Patients undergoing surgical procedures requiring cardiopulmonary bypass

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Troesch Medical Center

Loma Linda, California, 92354, United States

RECRUITING

Related Publications (5)

• Iwasaki H, Yamamoto M, Sato H, Doshu-Kajiura A, Kitajima O, Takagi S, Luthe SK, Suzuki T. A Comparison Between the Adductor Pollicis Muscle Using TOF-Watch SX and the Abductor Digiti Minimi Muscle Using TetraGraph in Rocuronium-Induced Neuromuscular Block: A Prospective Observational Study. Anesth Analg. 2022 Aug 1;135(2):370-375. doi: 10.1213/ANE.0000000000005897. Epub 2022 Jan 21.

  PMID: 35061641 BACKGROUND

• Ortiz R, Westenberg RF, Langhammer CG, Knaus WJ, Chen NC, Eberlin KR. Nerve Diameter in the Hand: A Cadaveric Study. Plast Reconstr Surg Glob Open. 2019 Mar 13;7(3):e2155. doi: 10.1097/GOX.0000000000002155. eCollection 2019 Mar.

  PMID: 31044121 BACKGROUND

• Duvaldestin P, Kuizenga K, Saldien V, Claudius C, Servin F, Klein J, Debaene B, Heeringa M. A randomized, dose-response study of sugammadex given for the reversal of deep rocuronium- or vecuronium-induced neuromuscular blockade under sevoflurane anesthesia. Anesth Analg. 2010 Jan 1;110(1):74-82. doi: 10.1213/ANE.0b013e3181c3be3c. Epub 2009 Nov 21.

  PMID: 19933538 BACKGROUND

• Lee HJ, Kim KS, Shim JC, Yoon SW. A comparison of the accuracy of ulnar versus median nerve stimulation for neuromuscular monitoring. Korean J Anesthesiol. 2011 May;60(5):334-8. doi: 10.4097/kjae.2011.60.5.334. Epub 2011 May 31.

  PMID: 21716963 BACKGROUND

• Bowdle A, Bussey L, Michaelsen K, Jelacic S, Nair B, Togashi K, Hulvershorn J. A comparison of a prototype electromyograph vs. a mechanomyograph and an acceleromyograph for assessment of neuromuscular blockade. Anaesthesia. 2020 Feb;75(2):187-195. doi: 10.1111/anae.14872. Epub 2019 Oct 16.

  PMID: 31617199 BACKGROUND

Study Officials

• Michael Benggon, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa D McCabe, MD, MSCR

CONTACT

909 558 4475; mmccabe@llu.edu

Michael Benggon, MD

CONTACT

909 558 4475; mbenggon@llu.edu

Study Design

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

Study Record Dates

• First Submitted: August 10, 2024
• First Posted: August 14, 2024
• Study Start: December 26, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

US (1)