- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04581720
Minimum Current for Train-of-four Monitoring
July 8, 2021 updated by: Sooyoung Cho, Ewha Womans University Mokdong Hospital
Determination of the Minimum Current for Train-of-four Monitoring by Acceleromyography and Electromyography During the Recovery From General Anesthesia
Neuromuscular monitoring during general anesthesia is important to make sure adequate muscle relaxation during operation and adequate recovery of muscle power and spontaneous breathing during emergence from general anesthesia.
The neuromuscular monitoring is usually using electrical stimulants and the method called train-of-four (TOF) is representative.
Because it uses electrical stimulants, the patients could be uncomfortable and feel pain during the monitoring when the patients are conscious.
Lowering the current of the stimulants would be helpful in reducing the pain, but there is a concern that the TOF results performed in lower current would be underestimated or inaccurate.
Therefore, the investigators want to find the minimal current for TOF monitoring that shows adequate TOF results.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Seoul, Korea, Republic of, 07985
- Ewha Womans University Mokdong Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 20-65
- Scheduled for an elective surgery
- ASA physical status 1 or 2
Exclusion Criteria:
- BMI > 25 kg/m2
- Neuromuscular disease
- Decreased renal function
- Neurologic disorder
- Impossible to cooperate or communicate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Participants
The participants will be applied AMG and EMG on each arm of both arms when they finish routine monitoring before the induction of general anesthesia.
After the participants being unconscious, we will find each participant's supramaximal current before injecting the neuromuscular blocking agents.
During the operation, when the TOF count reaches 4 again and the height of T1 reaches 50% of baseline, we perform TOF tests using 4 currents (Supramaximal current, 0.7×supramaximal current, 0.5×supramaximal current, 0.3×supramaximal current), three times for respective current to figure out that low current can show the same level of TOF ratio as the supramaximal current.
When the operation ends and the T1 reaches 100% of baseline, we perform TOF tests with 4 currents again.
In the postanesthesia care unit, we use EMG only and perform TOF tests with 4 currents again.
The participants can feel pain by the stimulants during the tests, so if they refuse the tests, we stop the tests and record it.
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Give 4 electrical stimulants on the ulnar nerve to see if the 4 responses (T1 ~ T4) of adductor pollicis fade or not.
If there's no neuromuscular block, it shows no fade, or it fades.
When an operation is over under general anesthesia, we use the ratio of the height of T4 to T1, and the ratio is over 90%, the neuromuscular block is recovered enough to extubation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Minimal current for TOF
Time Frame: During the operation, from the height of T1 reaches back to the baseline, to the extubation of tracheal tube when the general anesthesia is over.
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The minimal current among the four currents we use which is showing not significantly lower TOF ratio than TOF ratio of supramaximal stimulant.
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During the operation, from the height of T1 reaches back to the baseline, to the extubation of tracheal tube when the general anesthesia is over.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 12, 2020
Primary Completion (Actual)
July 6, 2021
Study Completion (Actual)
July 6, 2021
Study Registration Dates
First Submitted
September 27, 2020
First Submitted That Met QC Criteria
October 6, 2020
First Posted (Actual)
October 9, 2020
Study Record Updates
Last Update Posted (Actual)
July 9, 2021
Last Update Submitted That Met QC Criteria
July 8, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2020-06-017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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