Median Versus Ulnar Nerve Quantitative Electromyography Neuromuscular Blockade Monitoring Comparison

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorLoma Linda University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Contraindication to rocuronium use

Neuromuscular disease

Expected or known difficult airway

Rocuronium allergy

Trial population

Patients scheduled for elective surgery at Loma Linda University Medical Center

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Surgical Patients Receiving Non-Depolarizing Neuromuscular Blockade1 intervention

Trial outcomes

Primary outcomes

1

Neuromuscular transmission nerve monitoring concordance

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

Time frame
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

1

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

Time from rocuronium administration to the patient having 1 Train-of-Four twitch after appearance of first post-tetanic twitch, on both monitors

Time frame
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
2

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

Time from rocuronium administration to the patient having 2 Train-of-Four twitches after appearance of first Train-of-Four twitch, on both monitors

Time frame
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
3

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

Time from reversal at 2 or more Train-of-Four twitches with sugammadex administration to the patient having a Train-of-Four ratio greater than or equal to 0.9, or 90 percent, on both monitors

Time frame
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

Other outcomes

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