AnesthesiaNCT06467448
Comparing Train-of-Four Recovery in the Adductor Pollicis Versus the Adductor Digiti Minimi in Elective Surgery Patients
An observational study of Anesthesia and Neuromuscular Blockade, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The train-of-four (TOF) ratio is a quantitative measure used in anesthesia to assess the degree of neuromuscular blockade induced by neuromuscular blocking agents during surgical procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Neuromuscular Blockade
- What is being tested?
- EMG Assessement of Recovery of Neuromuscular Function
- Type of treatment
- Medical device
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2024to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Consented patients undergoing general anesthesia with an endotracheal tube and non depolarizing muscle relaxants and objective monitoring of train of four.
Who may be able to join
- Surgery and general anesthesia with administration of non depolarizing neuromuscular blocking drug
Who cannot join
- neuromuscular disease or weakness of one of upper limbs.
- Inability to use one of subjects arms to record neuromuscular monitor.
- Contraindication to administration or allergy to non depolarizing neuromuscular blocking drug.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Comparing Train-of-Four Recovery in the Adductor Pollicis Versus the Adductor Digiti Minimi in Elective Surgery Patients Using EMG
The train-of-four (TOF) ratio is a quantitative measure used in anesthesia to assess the degree of neuromuscular blockade induced by neuromuscular blocking agents during surgical procedures. Current American Society of Anesthesiologists guidelines recommend monitoring the TOF ratio to guide the administration and reversal of NMBAs, with a target ratio of 0.9 or higher at adductor pollicis muscle indicating adequate reversal and restoration of neuromuscular function.
This proposed study aims to observe and compare the TOF ratio between two different muscles of the hand: adductor pollicis and adductor digiti minim using anesthesia monitors on both of their arms during recovery of neuromuscular function. Surgery and anesthesia will occur per standard of care.
Read the detailed description
The study population will enroll adult patients (>18) who will receive non-depolarizing neuromuscular blocking drugs as part of a routine general anesthetic and who will have monitoring of their recovery from neuromuscular block performed using the Tetragraph (Senzime Sweden). Patients with upper limb weakness, neurological deficits, and inability to use the other arm to record the second EMG recording will be excluded.
Procedures (methods):
Adult patients undergoing general anesthesia with the use of muscle relaxants will have anesthesia monitors on both of their arms. On one arm, the study sticky pad will be placed on the forearm and over the base of the little finger. On the other arm, the standard monitor is placed on the forearm and over the base of the thumb.
To identify pre-operative patients, an EPIC report will be utilized to screen for eligible participants. Patients will be contacted via phone by a research team member the day before their procedure and enrolled. Informed consent will be formally obtained on the day of the procedure.
- Conditions
- Anesthesia, Neuromuscular Blockade
- Being tested
- EMG Assessement of Recovery of Neuromuscular Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMG Assessement of Recovery of Neuromuscular FunctionDevice
EMG Train of Four Assessment of Recovery of Neuromuscular Function
| Study group | Role | What they receive |
|---|---|---|
| Adductor Pollicis EMG | The Train of Four Ratio will be recorded at 90% as a time and as a reference point Receives: Device: EMG Assessement of Recovery of Neuromuscular Function | |
| Adductor Digiti Minimi | The Train of Four Ratio will be recorded when the adductor pollicis ratio reads 90% Receives: Device: EMG Assessement of Recovery of Neuromuscular Function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Measured Recovery of Train of Four at Adductor Pollicis and Adductor Digiti Minimi
The train of four ratio at the digiti minimi will be recorded when the adductor pollicis ratio reads 90 percent
Measured: All assessments are intraoperative and complete in one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start18 Mar 2024
- Primary completion9 May 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stuart Grant, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467448
- Sponsor's protocol ID
- 24-1013
- Status last verified
- May 2025
- First submitted
- 14 Jun 2024
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Train-of-Four Recovery in the Adductor Pollicis Versus the Adductor Digiti Minimi in Elective Surgery Patients Using EMG
- ClinicalTrials.gov ID
- NCT06467448
- Acronym / sponsor ID
- 24-1013
- Conditions
- Anesthesia, Neuromuscular Blockade
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 21 Jun 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.
The train-of-four (TOF) ratio is a quantitative measure used in anesthesia to assess the degree of neuromuscular blockade induced by neuromuscular blocking agents during surgical procedures. Current American Society of Anesthesiologists guidelines recommend monitoring the TOF ratio to guide the administration and reversal of NMBAs, with a target ratio of 0.9 or higher at adductor pollicis muscle indicating adequate reversal and restoration of neuromuscular function.
This proposed study aims to observe and compare the TOF ratio between two different muscles of the hand: adductor pollicis and adductor digiti minim using anesthesia monitors on both of their arms during recovery of neuromuscular function. Surgery and anesthesia will occur per standard of care.
Detailed description
The study population will enroll adult patients (>18) who will receive non-depolarizing neuromuscular blocking drugs as part of a routine general anesthetic and who will have monitoring of their recovery from neuromuscular block performed using the Tetragraph (Senzime Sweden). Patients with upper limb weakness, neurological deficits, and inability to use the other arm to record the second EMG recording will be excluded.
Procedures (methods):
Adult patients undergoing general anesthesia with the use of muscle relaxants will have anesthesia monitors on both of their arms. On one arm, the study sticky pad will be placed on the forearm and over the base of the little finger. On the other arm, the standard monitor is placed on the forearm and over the base of the thumb.
To identify pre-operative patients, an EPIC report will be utilized to screen for eligible participants. Patients will be contacted via phone by a research team member the day before their procedure and enrolled. Informed consent will be formally obtained on the day of the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adductor Pollicis EMG | – | Device: EMG Assessement of Recovery of Neuromuscular FunctionThe Train of Four Ratio will be recorded at 90% as a time and as a reference point |
| Adductor Digiti Minimi | – | Device: EMG Assessement of Recovery of Neuromuscular FunctionThe Train of Four Ratio will be recorded when the adductor pollicis ratio reads 90% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consented patients undergoing general anesthesia with an endotracheal tube and non depolarizing muscle relaxants and objective monitoring of train of four.
Key inclusion criteria (1 listed)
- Surgery and general anesthesia with administration of non depolarizing neuromuscular blocking drug
Key exclusion criteria (3 listed)
- neuromuscular disease or weakness of one of upper limbs.
- Inability to use one of subjects arms to record neuromuscular monitor.
- Contraindication to administration or allergy to non depolarizing neuromuscular blocking drug.
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 |
|---|---|---|
| EMG Assessement of Recovery of Neuromuscular FunctionEMG Train of Four Assessment of Recovery of Neuromuscular Function | Device | Adductor Digiti Minimi, Adductor Pollicis EMG |
Primary outcome
Difference in Measured Recovery of Train of Four at Adductor Pollicis and Adductor Digiti Minimi
Time frame: All assessments are intraoperative and complete in one day
The train of four ratio at the digiti minimi will be recorded when the adductor pollicis ratio reads 90 percent
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Stuart Grant principal investigator
University of North Carolina, Chapel Hill
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 Anesthesia and Neuromuscular Blockade, run by University of North Carolina, Chapel Hill 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 13 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Measured Recovery of Train of Four at Adductor Pollicis and Adductor Digiti Minimi (time frame: All assessments are intraoperative and complete in one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2026.