Bladder TumorCurrent_ONBNCT05872451
Current Intensity for the Obturator Nerve Block
A study testing Rocuronium Bromide and Nerve stimulator in people with Bladder Tumor, run by Chosun University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Tumor
- What is being tested?
- Rocuronium Bromide and Nerve stimulator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2023to 15 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing TURP procedure
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Difference in the Current Intensity for the Obturator Nerve Block According to the Presence or Absence of Neuromuscular Blockage
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.
Read the 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.
- Conditions
- Bladder Tumor
- Being tested
- Rocuronium Bromide, Nerve stimulator
- Keywords
- Transurethral Resection of Bladder, Obturator Nerve, Nerve Block, Neuromuscular Blockade, Anesthesia, General
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium BromideDrug
Also called Rocuronium
After measuring the initial current intensity, quantitative neuromuscular blockade monitoring is applied, and rocuronium (0.6 mg/kg) is administered.
Nerve stimulatorDiagnostic test
Also called Stimuplex
Measuring the minimum current intensity for the stimulation of the obturator nerve to show the contraction of the adductor longus muscle.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Rocuronium Bromide; Diagnostic Test: Nerve stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: About 10 minutes after starting obturator nerve block procedure
Secondary outcomes (1)
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.
Measured: Between 5 minutes and 10 minutes after starting obturator nerve block procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Jul 2023
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients undergoing TURP procedure under general anesthesia
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chosun University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki Tae Jung, Chosun University Hospital
- Investigators
- Ki Tae Jung, M.D., Ph.D., Study chair, Chosun University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872451
- Sponsor's protocol ID
- ONB
- Acronym
- Current_ONB
- Status last verified
- Aug 2024
- First submitted
- 12 May 2023
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31842248
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Difference in the Current Intensity for the Obturator Nerve Block According to the Presence or Absence of Neuromuscular Blockage
- ClinicalTrials.gov ID
- NCT05872451
- Acronym / sponsor ID
- Current_ONB / ONB
- Conditions
- Bladder Tumor
- Keywords
- Transurethral Resection of Bladder, Obturator Nerve, Nerve Block, Neuromuscular Blockade, Anesthesia, General
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chosun University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients undergoing TURP procedure under general anesthesia
| Arm | Type | Receives |
|---|---|---|
| Current intensity | Experimental | Drug: Rocuronium Bromide, Diagnostic Test: Nerve stimulator1. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing TURP procedure
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rocuronium BromideAlso: RocuroniumAfter measuring the initial current intensity, quantitative neuromuscular blockade monitoring is applied, and rocuronium (0.6 mg/kg) is administered. | Drug | Current intensity |
| Nerve stimulatorAlso: StimuplexMeasuring the minimum current intensity for the stimulation of the obturator nerve to show the contraction of the adductor longus muscle. | Diagnostic test | Current intensity |
Primary outcome
Initial current intensity
Time frame: 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.
Final current intensity
Time frame: 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.
1 secondary outcome
Current intensity after the administration of rocuronium (0.6 mg/kg)
Time frame: Between 5 minutes and 10 minutes after starting obturator nerve block procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Background: PubMed 31842248Koo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ki Tae Jung, M.D., Ph.D. study chair
Chosun University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rocuronium Bromide and Nerve stimulator in people with Bladder Tumor, run by Chosun University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial current intensity (time frame: About 5 minutes after starting obturator nerve block procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05872451, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024; AzTrials last refreshed its copy on 29 Oct 2026.