Neuromuscular BlockadeNCT07759206
Gentle Skin Abrasion and EMG-Based Neuromuscular Blockade Monitoring
A study testing Gentle Skin Abrasion Before EMG-Based Neuromuscular Blockade Monitoring in people with Neuromuscular Blockade and Intraoperative Monitoring, run by University of Minnesota at 1 site in United States.
Trial summary
This study will evaluate whether gentle skin abrasion improves electromyographic signal quality during neuromuscular blockade monitoring in adult surgical patients. Participants will receive standard TwitchView electromyographic neuromuscular blockade monitoring on one wrist and TwitchView monitoring after gentle skin… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Blockade, Intraoperative Monitoring, Skin Preparation
- What is being tested?
- Gentle Skin Abrasion Before EMG-Based Neuromuscular Blockade Monitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2023to 28 Feb 2024
- Phase
- Interventional
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult surgical patient aged 18 years or older
- Classified as American Society of Anesthesiologists Physical Status I, II, or III
- Scheduled to undergo an elective procedure in which use of a neuromuscular blocking drug is anticipated
- Neuromuscular blockade monitoring would be standard care for the planned procedure
- Procedure allows access to both wrists
- Capable of signing informed consent
Who cannot join
- Emergency procedure
- Procedure in which neuromuscular blocking drugs are not anticipated
- Access to at least one wrist and ankle is not possible
- Unable to provide informed consent
- Prior stroke
- Hemiparesis or hemiplegia
Show all 9Show fewer
- Any other known neuromuscular disorder
- Employee or student of the researcher
- Pregnant women, fetuses, neonates, prisoners, children, or adults unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota East Bank Medical Center
Minneapolis, Minnesota, 55414
About this study
This study will evaluate whether gentle skin abrasion improves electromyographic signal quality during neuromuscular blockade monitoring in adult surgical patients.
Participants will receive standard TwitchView electromyographic neuromuscular blockade monitoring on one wrist and TwitchView monitoring after gentle skin abrasion on the opposite wrist. The study will compare electromyographic response amplitudes and supramaximal stimulus currents between routine electrode application and electrode application after skin preparation.
The study procedures will occur during scheduled surgery and will not alter the anesthetic or surgical management of participants.
Read the detailed description
Neuromuscular blocking agents are commonly used during adult surgical procedures. Quantitative neuromuscular blockade monitoring is used to assess the effects of these drugs and to guide clinical management of neuromuscular blockade and recovery. The TwitchView electromyographic monitor is routinely used for this purpose and uses surface electrodes placed over the ulnar nerve and hand muscles to generate train-of-four measurements.
In some patients, the electromyographic signal obtained with routine electrode application may be poor or inadequate for continuous monitoring. This may be related to skin condition, such as callouses, oily skin, or other factors that affect signal quality. Gentle skin abrasion is a technique commonly used in electrophysiology settings to improve the quality of physiologic electrical signals.
This study will compare electromyographic signals obtained from routinely applied TwitchView electrodes with signals obtained from TwitchView electrodes placed after gentle skin abrasion using 3M Red Dot Trace Prep abrasive strips. After consent is obtained and the participant is moved into the operating room, TwitchView electrodes will be applied to both wrists. One wrist will receive routine electrode application without skin preparation, while the opposite wrist will undergo gentle skin abrasion before standard TwitchView electrodes are applied. Two TwitchView monitors will be used, one for each electrode strip.
After induction of anesthesia, both TwitchView devices will be started. Other than a brief device start-up period, anesthetic and surgical management, including neuromuscular blocking drug dosing and timing, will be determined by the clinical care team and not by the investigators. The devices will record neuromuscular monitoring data during the procedure.
The primary outcome is the amplitude of recorded electromyographic responses to train-of-four stimulation after induction of anesthesia but before administration of a paralytic drug. Secondary outcomes include the supramaximal stimulus current determined by the device and electromyographic signal amplitudes after administration of neuromuscular blocking drugs.
- Being tested
- Gentle Skin Abrasion Before EMG-Based Neuromuscular Blockade Monitoring
- Keywords
- Gentle skin abrasion, Skin preparation, EMG monitoring, 3M Red Dot Trace Prep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentle Skin Abrasion Before EMG-Based Neuromuscular Blockade MonitoringProcedure or surgery
Also called Skin Preparation With 3M Red Dot Trace Prep
Gentle skin abrasion will be performed at the stimulus and recording electrode sites on one wrist using 3M Red Dot Trace Prep abrasive strips before applying standard TwitchView electrodes. The opposite wrist will receive routine electrode application without skin preparation. Two TwitchView monitors will be used to compare EMG signal amplitudes and supramaximal stimulus currents.
| Study group | Role | What they receive |
|---|---|---|
| Gentle Skin Abrasion and Standard Electrode Application | Experimental | Participants will receive standard TwitchView EMG-based neuromuscular blockade monitoring with routine electrode application on one wrist and EMG-based monitoring after gentle skin abrasion on the opposite wrist. EMG signal amplitudes and supramaximal stimulus currents will be compared between the routine and skin-prepped electrode sites within each participant. Receives: Procedure: Gentle Skin Abrasion Before EMG-Based Neuromuscular Blockade Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMG Response Amplitude Before Neuromuscular Blocking Drug Administration
Amplitude of recorded EMG responses to train-of-four stimulation will be compared between routine electrode application and electrodes placed after gentle skin abrasion.
Measured: During surgery, before paralytic drug administration
Secondary outcomes (2)
Supramaximal Stimulus Current
Supramaximal stimulus current determined by the TwitchView device will be compared between routine electrode application and electrodes placed after gentle skin abrasion.
Measured: During device startup after anesthesia induction
EMG Response Amplitude After Neuromuscular Blocking Drug Administration
EMG signal amplitudes after administration of neuromuscular blocking drugs will be compared between routine electrode application and electrodes placed after gentle skin abrasion.
Measured: During surgery, after paralytic drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start3 Oct 2023
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive standard EMG-based neuromuscular blockade monitoring on one wrist and EMG-based neuromuscular blockade monitoring after gentle skin abrasion on the opposite wrist. EMG signal amplitudes and supramaximal stimulus currents will be compared within participants.
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael M Todd, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759206
- Sponsor's protocol ID
- ANES-2023-32150
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No