- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06553131
Median Versus Ulnar Nerve Quantitative Electromyography Neuromuscular Blockade Monitoring Comparison
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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a single-center prospective, randomized controlled trial comparing ulnar versus median nerve electromyography transmission.
Neuromuscular blockade is used to provide muscle relaxation during surgery. The depth of neuromuscular blockade can be monitored with nerve stimulation or electromyography. The response to and recovery from non-depolarizing neuromuscular blockade is best described for the ulnar nerve. The investigators postulate that the median nerve may provide comparable information about the response non-depolarizing neuromuscular blockade. Electromyography electrodes will be positioned to stimulate the ulnar nerve in one arm and the median nerve in the other arm. The response to, and recovery from, non-depolarizing neuromuscular blockade will be compared between the ulnar and median nerve.
The location of median nerve monitoring will be randomized to the dominant or non-dominant hand.
The randomized arm will have electrodes positioned to stimulate the median nerve and the other arm will have electrodes positioned to stimulate the ulnar nerve (standard site for monitoring neuromuscular transmission during anesthesia).
The purpose of the study is to compare the response to, and recovery from, non-depolarizing neuromuscular blockade between the ulnar and median nerves.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Melissa D McCabe, MD, MSCR
- Phone Number: 44475 909 558 4475
- Email: mmccabe@llu.edu
Study Contact Backup
- Name: Michael Benggon, MD
- Phone Number: 44475 909 558 4475
- Email: mbenggon@llu.edu
Study Locations
-
-
California
-
Loma Linda, California, United States, 92354
- Recruiting
- Loma Linda University Troesch Medical Center
-
Contact:
- Melissa M McCabe, MD
- Phone Number: 909-558-4475
- Email: mmccabe@llu.edu
-
Principal Investigator:
- Melissa D McCabe, MD
-
Sub-Investigator:
- Richard L Applegate, MD
-
Sub-Investigator:
- Lauren S Pineda, MS
-
Sub-Investigator:
- Edgardo E Reynoso, BA
-
Sub-Investigator:
- Morgan E Blazy, BS
-
Contact:
- Morgan E Blazy, BS
- Phone Number: 44256 9095584227
- Email: MBlazy@llu.edu
-
Sub-Investigator:
- Michael Benggon, MD
-
Sub-Investigator:
- Ryan Lauer, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neuromuscular transmission nerve monitoring concordance
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Non-inferiority of median nerve neuromuscular monitoring compared to ulnar nerve neuromuscular monitoring - first train of four
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
|
Time from rocuronium administration to the patient having 1 Train-of-Four twitch after appearance of first post-tetanic twitch, on both monitors
|
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
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
|
Time from rocuronium administration to the patient having 2 Train-of-Four twitches after appearance of first Train-of-Four twitch, on both monitors
|
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
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
|
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
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Benggon, MD, Loma Linda University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- IRB 5240163
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.
Clinical Trials on Neuromuscular Blockade
-
Seoul National University Bundang HospitalCompletedNeuromuscular Blockade | Neuromuscular Blockade MonitoringSouth Korea
-
Hospital Federal de BonsucessoUnknownNeuromuscular Blockade | Magnesium Sulfate | Rocuronium | Deep Neuromuscular BlockadeBrazil
-
Universitair Ziekenhuis BrusselCompletedNeuromuscular Blockade | Neuromuscular MonitoringBelgium
-
Fondazione IRCCS Istituto Nazionale dei Tumori,...CompletedNeuromuscular Blockade | Neuromuscular MonitoringItaly
-
University Hospital of PatrasNot yet recruitingNeuromuscular Blockade
-
The Fourth Affiliated Hospital of Zhejiang University...RecruitingNeuromuscular BlockadeChina
-
Ciusss de L'Est de l'Île de MontréalRecruiting
-
University Hospital UlmNot yet recruitingNeuromuscular Blockade
-
Christoph CzarnetzkiOspedale Regionale di Lugano; Centre Hospitalier du Centre du ValaisRecruiting
-
Jiangsu HengRui Medicine Co., Ltd.CompletedNeuromuscular BlockadeChina
Clinical Trials on Neuromuscular Transmission Monitoring
-
Onze Lieve Vrouw HospitalCompleted
-
Brugmann University HospitalCompletedNeuromuscular BlockadeBelgium
-
Onze Lieve Vrouw HospitalMerck Sharp & Dohme LLCCompletedPostoperative Hypoxemia | Postoperative Residual Curarisation | Postoperative Airway ObstructionBelgium
-
Massachusetts General HospitalMerck Sharp & Dohme LLCUnknownResidual Paralysis, Post-AnesthesiaUnited States
-
University of PadovaUniversity Hospital, Padua, ItalyNot yet recruiting
-
Samsung Medical CenterCompletedNeuromuscular Blockade | Hemifacial Spasm | Microvascular DecompressionKorea, Republic of
-
Tamas Vegh, MDSenzime ABCompletedNeuromuscular BlockadeHungary
-
University of California, DavisRecruiting
-
Biotronik SE & Co. KGTerminatedVentricular Tachyarrhythmia | Cardiac Pacing | Electric CountershockGermany
-
King Saud UniversityUnknownBariatric Surgery CandidateSaudi Arabia