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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04581720
Other study ID # 2020-06-017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 12, 2020
Est. completion date July 6, 2021

Study information

Verified date July 2021
Source Ewha Womans University Mokdong Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date July 6, 2021
Est. primary completion date July 6, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Korea, Republic of Ewha Womans University Mokdong Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Ewha Womans University Mokdong Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Minimal current for TOF The minimal current among the four currents we use which is showing not significantly lower TOF ratio than TOF ratio of supramaximal stimulant. 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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