Minimum Current for Train-of-four Monitoring

Sponsor

Ewha Womans University Mokdong Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04581720

Collaborator

(none)

Enrollment

Location

Arm

8.8

Actual Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia Anesthesia Recovery Period Neuromuscular Blockade	Device: Train-of-four (TOF)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Determination of the Minimum Current for Train-of-four Monitoring by Acceleromyography and Electromyography During the Recovery From General Anesthesia

Actual Study Start Date :

Oct 12, 2020

Actual Primary Completion Date :

Jul 6, 2021

Actual Study Completion Date :

Jul 6, 2021

Arms and Interventions

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.	Device: Train-of-four (TOF) 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.

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.

Device: Train-of-four (TOF)

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.

Outcome Measures

Primary Outcome Measures

Minimal current for TOF [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.]
The minimal current among the four currents we use which is showing not significantly lower TOF ratio than TOF ratio of supramaximal stimulant.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ewha Womans University Mokdong Hospital	Seoul		Korea, Republic of	07985

Sponsors and Collaborators

Ewha Womans University Mokdong Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sooyoung Cho, Clinical Assistant Professor, Ewha Womans University Mokdong Hospital

ClinicalTrials.gov Identifier:

NCT04581720

Other Study ID Numbers:

2020-06-017

First Posted:

Oct 9, 2020

Last Update Posted:

Jul 9, 2021

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 9, 2021