Minimum Current for Train-of-four Monitoring

NCT ID: NCT04581720

Last Updated: 2021-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-12
• Study Completion Date: 2021-07-06

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.

Conditions

Anesthesia; Anesthesia Recovery Period; Neuromuscular Blockade

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Train-of-four (TOF)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ewha Womans University Mokdong Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sooyoung Cho

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2020-06-017

Identifier Type: -

Identifier Source: org_study_id