UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053918 |
|---|---|
| Receipt number | R000061543 |
| Scientific Title | A novel stimulating electrode attachment method designed to maintain electromyography-based neuromuscular monitoring detectability during laparoscopic surgery: a single-center randomized, double-blind, controlled study |
| Date of disclosure of the study information | 2024/03/20 |
| Last modified on | 2024/04/22 23:23:33 |
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Basic information
Public title
A novel stimulating electrode attachment method designed to maintain electromyography-based neuromuscular monitoring detectability during laparoscopic surgery: a single-center randomized, double-blind, controlled study
Acronym
A novel stimulating electrode attachment method designed to maintain electromyography-based neuromuscular monitoring detectability during laparoscopic surgery: a single-center randomized, double-blind, controlled study
Scientific Title
A novel stimulating electrode attachment method designed to maintain electromyography-based neuromuscular monitoring detectability during laparoscopic surgery: a single-center randomized, double-blind, controlled study
Scientific Title:Acronym
A novel stimulating electrode attachment method designed to maintain electromyography-based neuromuscular monitoring detectability during laparoscopic surgery: a single-center randomized, double-blind, controlled study
Region
| Japan |
Condition
Condition
Patients with upper gastrointestinal, lower gastrointestinal, hepatobiliary, gynecologic, or urologic diseases undergoing laparoscopic surgery in the 0 degrees pronation in both upper limb position
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Obstetrics and Gynecology | Urology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We demonstrate that even patients with low monitoring detectability for the recovery process of the muscle response after rocuronium administration in the original attachment method recommended by Nihon-Kohden (revised June 2022) can be monitored with high detectability using the attachment method in which the line connecting the centers of the anode and cathode of the stimulating electrode crosses the ulnar nerve. We also examine the monitoring detectability with the modified attachment method recommended by Nihon-Kohden (revised January 2023).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to the appearance of the first post-tetanic count (PTC) after the first rocuronium administration
Key secondary outcomes
The stimulus current value and sensitivity at calibration, time to the appearance of the first train-of-four (TOF) count after the first rocuronium administration, total PTC counts every two hours after positional change, time to the appearance of the TOF counts one, two, three, and four after the last rocuronium administration, the TOF counts or the TOF ratio and the amplitudes of T1 before and after sugammadex administration, time to the TOF ratio greater than 0.9 after sugammadex administration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
The electromyography electrode, NM-345Y, is attached such that the line connecting the centers of the anode and cathode of the stimulating electrode crosses the ulnar nerve.
Interventions/Control_2
The NM-345Y is placed as described in the AF-201P Instruction Manual by Nihon-Kohden (revised June 6, 2022).
Interventions/Control_3
The NM-345Y is placed as described in the AF-201P Instruction Manual by Nihon-Kohden (revised January, 2023).
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age: 18 years old or older
Surgery: Laparoscopic surgery in the 0 degrees pronation position of both upper limbs
Diseases: Upper gastrointestinal, lower gastrointestinal, hepatobiliary, gynecologic, or urologic diseases
Key exclusion criteria
Patients who already have neurological disorders (e.g., paralysis)
Patients with neuromuscular diseases
Patients with pacemakers or implantable cardioverter defibrillators
Pregnant women
Patients with fragile skin where the electromyography electrode seal is attached
Patients with a history of surgery on the measuring limb
Patients with a history of allergy to rocuronium or sugammadex
Patients undergoing hemodialysis
Patients undergoing robot-assisted laparoscopic surgery
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Shohei |
| Middle name | |
| Last name | Kaneko |
Organization
Nagasaki University Hospital
Division name
Department of Anesthesiology
Zip code
852-8116
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7370
s-kaneko@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Shohei |
| Middle name | |
| Last name | Kaneko |
Organization
Nagasaki University Hospital
Division name
Department of Anesthesiology
Zip code
852-8116
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7370
Homepage URL
s-kaneko@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki
Tel
095-819-7229
gaibushikin@ml.nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
長崎大学病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 20 | Day |
Last modified on
| 2024 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061543
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