Neuromuscular BlockadeNCT06553131
Median Versus Ulnar Nerve Quantitative Electromyography Neuromuscular Blockade Monitoring Comparison
An observational study of Neuromuscular Blockade, run by Loma Linda University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Neuromuscular Transmission Monitoring
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Dec 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective surgery at Loma Linda University Medical Center
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Loma Linda University Troesch Medical Center
Loma Linda, California, 92354
Melissa M McCabe, MD, 909-558-4475, mmccabe@llu.edu
Morgan E Blazy, BS, 9095584227 ext. 44256, MBlazy@llu.edu
About this study
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).
Read the 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.
- Conditions
- Neuromuscular Blockade
- Being tested
- Neuromuscular Transmission Monitoring
- Keywords
- Median Nerve, Neuromuscular Blockade, Ulnar Nerve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Transmission MonitoringDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Neuromuscular Transmission Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuromuscular transmission nerve monitoring concordance
The length of time between rocuronium administration and first post-tetanic twitch for both nerves
Measured: 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
Time from rocuronium administration to the patient having 1 Train-of-Four twitch after appearance of first post-tetanic twitch, on both monitors
Measured: 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 from rocuronium administration to the patient having 2 Train-of-Four twitches after appearance of first Train-of-Four twitch, on both monitors
Measured: 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 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start26 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Benggon, MD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553131
- Sponsor's protocol ID
- IRB 5240163
- Status last verified
- Jan 2026
- First submitted
- 10 Aug 2024
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 35061641Ortiz 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.
PubMed 31044121Duvaldestin 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.
PubMed 19933538Lee 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.
PubMed 21716963Bowdle 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.
PubMed 31617199
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Median Versus Ulnar Nerve Quantitative Electromyography Neuromuscular Blockade Monitoring Comparison
- ClinicalTrials.gov ID
- NCT06553131
- Acronym / sponsor ID
- IRB 5240163
- Conditions
- Neuromuscular Blockade
- Keywords
- Median Nerve, Neuromuscular Blockade, Ulnar Nerve
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 26 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Patients Receiving Non-Depolarizing Neuromuscular Blockade | – | Device: Neuromuscular Transmission MonitoringSurgical 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective surgery at Loma Linda University Medical Center
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular Transmission MonitoringA 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 | Device | Surgical Patients Receiving Non-Depolarizing Neuromuscular Blockade |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Background: PubMed 35061641Iwasaki 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.
- Background: PubMed 31044121Ortiz 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.
- Background: PubMed 19933538Duvaldestin 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.
- Background: PubMed 21716963Lee 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.
- Background: PubMed 31617199Bowdle 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Benggon, MD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Blockade, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa D McCabe, MD, MSCR (909 558 4475 ext. 44475, mmccabe@llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06553131, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.