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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05872451
Other study ID # ONB
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date April 30, 2024

Study information

Verified date August 2023
Source Chosun University Hospital
Contact Ki Tae Jung, M.D., Ph.D.
Phone +82-62-220-3223
Email mdmole@chosun.ac.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the present study was to find out the difference in current intensity required for nerve stimulation according to the presence or absence of neuromuscular blockade during the obturator nerve block procedure for TURP.


Description:

During the transurethral resection of bladder tumors (TURBT) procedure under spinal anesthesia, the obturator nerve block is required to prevent the accidental movement of adductor longus muscles by electrical stimulation. However, during general anesthesia, the contraction of the adductor longus muscle would be lost due to deep neuromuscular blockade. However, some reports showed that the contraction of the adductor longus muscle occurs even in the deep neuromuscular blockade. The current intensity for the nerve stimulation during nerve block is 0.3--0.5 mA when the needle tip is near the nerve. However, it is still unknown what current intensity is required to show the contraction of the adductor longus muscle when the patient is in a deep neuromuscular blockade. Therefore, in this study, investigators aimed to determine the difference in current intensity required for nerve stimulation according to the presence or absence of neuromuscular blockade during obturator nerve block for TURP. In addition, investigators aimed to determine that the obturator nerve block is required during the TURP procedure in patients with deep neuromuscular blockade during general anesthesia.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients undergoing TURP procedure Exclusion Criteria: - Patients with anatomical or functional anomaly in the upper airways - Patients with neuromuscular disease - Patients with hip joint disorders - BMI of < 18.5 or > 30.0 kg/m2

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rocuronium Bromide
After measuring the initial current intensity, quantitative neuromuscular blockade monitoring is applied, and rocuronium (0.6 mg/kg) is administered.
Diagnostic Test:
Nerve stimulator
Measuring the minimum current intensity for the stimulation of the obturator nerve to show the contraction of the adductor longus muscle.

Locations

Country Name City State
Korea, Republic of Chosun University Hospital Gwangju

Sponsors (1)

Lead Sponsor Collaborator
Chosun University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Koo CH, Ryu JH. Anesthetic considerations for urologic surgeries. Korean J Anesthesiol. 2020 Apr;73(2):92-102. doi: 10.4097/kja.19437. Epub 2019 Dec 17. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Initial current intensity The current intensity for the stimulation of the obturator nerve starts at 1.0 mA (using the sequential electrical nerve stimulation mode), and the needle is advanced gradually to the location where the stimulus response occurs at 0.3-0.5 mA. After fixing the needle position in a position where contraction of the adductor longus muscle responds to the minimum current intensity, measure the current intensity. About 5 minutes after starting obturator nerve block procedure
Primary Final current intensity After administration of rocuronium (0.6 mg/kg), when the train-of-four count becomes 0, the current intensity for the stimulation of the obturator nerve is increased until the contraction of the adductor longus muscle occurs. The current intensity is measured when the contraction of the adductor longus muscle occurs. About 10 minutes after starting obturator nerve block procedure
Secondary Current intensity after the administration of rocuronium (0.6 mg/kg) After administration of rocuronium (0.6 mg/kg), the quantitative neuromuscular blockade monitoring using train-of-four is observed with 12 seconds interval. At each time point, the current intensity for the obturator nerve is increased until the contraction of the adductor longus muscle occurs. The current intensity at each time point is measured. Between 5 minutes and 10 minutes after starting obturator nerve block procedure
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