NCT05872451

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2024

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

10 months

First QC Date

May 12, 2023

Last Update Submit

August 21, 2024

Conditions

Keywords

Transurethral Resection of BladderObturator NerveNerve BlockNeuromuscular BlockadeAnesthesia, General

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Current intensity after the administration of rocuronium (0.6 mg/kg)

    Between 5 minutes and 10 minutes after starting obturator nerve block procedure

Study Arms (1)

Current intensity

EXPERIMENTAL

1. An I-gel mask is inserted for the mechanical ventilator of the patient who is sedated with propofol. 2. For the ultrasound-guided obturator nerve (ON) block, and needle tip gradually advanced to the anterior branch of the ON. The current intensity for the stimulation of ON starts at 1.0 mA (using the sequential electrical nerve stimulation mode), and the needle is advanced gradually to the location where the contraction of the adductor longus muscle (ALM) occurs at 0.3-0.5 mA. 3. After fixing the needle in that position, measure the current intensity. 4. Then, rocuronium (0.6 mg/kg) is administered under quantitative neuromuscular-blockade monitoring. 5. When the train-of-four count becomes 0, the current intensity is increased until the contraction of the ALM occurs. 6. The current intensity is measured when the contraction of the ALM occurs.

Drug: Rocuronium BromideDiagnostic Test: Nerve stimulator

Interventions

After measuring the initial current intensity, quantitative neuromuscular blockade monitoring is applied, and rocuronium (0.6 mg/kg) is administered.

Also known as: Rocuronium
Current intensity
Nerve stimulatorDIAGNOSTIC_TEST

Measuring the minimum current intensity for the stimulation of the obturator nerve to show the contraction of the adductor longus muscle.

Also known as: Stimuplex
Current intensity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing TURP procedure

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chosun University Hospital

Gwangju, 61453, South Korea

Location

Related 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.

    PMID: 31842248BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Ki Tae Jung, M.D., Ph.D.

    Chosun University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Patients undergoing TURP procedure under general anesthesia
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 12, 2023

First Posted

May 24, 2023

Study Start

July 1, 2023

Primary Completion

April 15, 2024

Study Completion

April 15, 2024

Last Updated

August 22, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations