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Current Intensity for the Obturator Nerve Block (Current_ONB)

Primary Purpose

Bladder Tumor

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rocuronium Bromide
Nerve stimulator
Sponsored by
Chosun University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bladder Tumor focused on measuring Transurethral Resection of Bladder, Obturator Nerve, Nerve Block, Neuromuscular Blockade, Anesthesia, General

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chosun University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Current intensity

Arm Description

An I-gel mask is inserted for the mechanical ventilator of the patient who is sedated with propofol. 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. After fixing the needle in that position, measure the current intensity. Then, rocuronium (0.6 mg/kg) is administered under quantitative neuromuscular-blockade monitoring. When the train-of-four count becomes 0, the current intensity is increased until the contraction of the ALM occurs. The current intensity is measured when the contraction of the ALM occurs.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 12, 2023
Last Updated
August 28, 2023
Sponsor
Chosun University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05872451
Brief Title
Current Intensity for the Obturator Nerve Block
Acronym
Current_ONB
Official Title
The Difference in the Current Intensity for the Obturator Nerve Block According to the Presence or Absence of Neuromuscular Blockage
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chosun University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Tumor
Keywords
Transurethral Resection of Bladder, Obturator Nerve, Nerve Block, Neuromuscular Blockade, Anesthesia, General

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients undergoing TURP procedure under general anesthesia
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Current intensity
Arm Type
Experimental
Arm Description
An I-gel mask is inserted for the mechanical ventilator of the patient who is sedated with propofol. 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. After fixing the needle in that position, measure the current intensity. Then, rocuronium (0.6 mg/kg) is administered under quantitative neuromuscular-blockade monitoring. When the train-of-four count becomes 0, the current intensity is increased until the contraction of the ALM occurs. The current intensity is measured when the contraction of the ALM occurs.
Intervention Type
Drug
Intervention Name(s)
Rocuronium Bromide
Other Intervention Name(s)
Rocuronium
Intervention Description
After measuring the initial current intensity, quantitative neuromuscular blockade monitoring is applied, and rocuronium (0.6 mg/kg) is administered.
Intervention Type
Diagnostic Test
Intervention Name(s)
Nerve stimulator
Other Intervention Name(s)
Stimuplex
Intervention Description
Measuring the minimum current intensity for the stimulation of the obturator nerve to show the contraction of the adductor longus muscle.
Primary Outcome Measure Information:
Title
Initial current intensity
Description
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.
Time Frame
About 5 minutes after starting obturator nerve block procedure
Title
Final current intensity
Description
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.
Time Frame
About 10 minutes after starting obturator nerve block procedure
Secondary Outcome Measure Information:
Title
Current intensity after the administration of rocuronium (0.6 mg/kg)
Description
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.
Time Frame
Between 5 minutes and 10 minutes after starting obturator nerve block procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ki Tae Jung, M.D., Ph.D.
Phone
+82-62-220-3223
Email
mdmole@chosun.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki Tae Jung, M.D., Ph.D.
Organizational Affiliation
Chosun University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chosun University Hospital
City
Gwangju
ZIP/Postal Code
61453
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ki Tae Jung, M.D., Ph.D.
Phone
+82-62-220-3223
Email
mdmole@chosun.ac.kr
First Name & Middle Initial & Last Name & Degree
Su Yeon Cho, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31842248
Citation
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.
Results Reference
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Current Intensity for the Obturator Nerve Block

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