Current_ONB: Current Intensity for the Obturator Nerve Block

Sponsor
Chosun University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05872451
Collaborator
(none)
30
1
1
11.3
2.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Rocuronium Bromide
  • Diagnostic Test: Nerve stimulator
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Patients undergoing TURP procedure under general anesthesiaPatients undergoing TURP procedure under general anesthesia
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Difference in the Current Intensity for the Obturator Nerve Block According to the Presence or Absence of Neuromuscular Blockage
Anticipated Study Start Date :
May 22, 2023
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Current intensity

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.

Drug: Rocuronium Bromide
After measuring the initial current intensity, quantitative neuromuscular blockade monitoring is applied, and rocuronium (0.6 mg/kg) is administered.
Other Names:
  • Rocuronium
  • 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.
    Other Names:
  • Stimuplex
  • Outcome Measures

    Primary Outcome Measures

    1. Initial current intensity [About 5 minutes after starting obturator nerve block procedure]

      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.

    2. Final current intensity [About 10 minutes after starting obturator nerve block procedure]

      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

    1. Current intensity after the administration of rocuronium (0.6 mg/kg) [Between 5 minutes and 10 minutes after starting obturator nerve block procedure]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chosun University Hospital Gwangju Korea, Republic of 61453

    Sponsors and Collaborators

    • Chosun University Hospital

    Investigators

    • Study Chair: Ki Tae Jung, M.D., Ph.D., Chosun University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ki Tae Jung, Professor, Chosun University Hospital
    ClinicalTrials.gov Identifier:
    NCT05872451
    Other Study ID Numbers:
    • ONB
    First Posted:
    May 24, 2023
    Last Update Posted:
    May 24, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ki Tae Jung, Professor, Chosun University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 24, 2023