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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038309
Receipt No. R000043664
Scientific Title Comparison between the trapezius and the adductor pollicis muscle as a monitoring site of acceleromyography for providing moderate neuromuscular blockade during lumbar spine surgery : a prospective randomized controlled trial
Date of disclosure of the study information 2019/11/01
Last modified on 2019/12/04

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Basic information
Public title Comparison between the trapezius and the adductor pollicis muscle as a monitoring site of acceleromyography for providing moderate neuromuscular blockade during lumbar spine surgery : a prospective randomized controlled trial
Acronym Comparison between the trapezius and the adductor pollicis muscle as a monitoring site of acceleromyography for providing moderate neuromuscular blockade during lumbar spine surgery : a prospective randomized controlled trial
Scientific Title Comparison between the trapezius and the adductor pollicis muscle as a monitoring site of acceleromyography for providing moderate neuromuscular blockade during lumbar spine surgery : a prospective randomized controlled trial
Scientific Title:Acronym Comparison between the trapezius and the adductor pollicis muscle as a monitoring site of acceleromyography for providing moderate neuromuscular blockade during lumbar spine surgery : a prospective randomized controlled trial
Region
Asia(except Japan)

Condition
Condition neuromuscular blockade monitoring during lumbar spinal surgery
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aimed to investigate feasibility of neuromuscular blockade (NMB) monitoring using acceleromyography at the trapezius muscle
Basic objectives2 Others
Basic objectives -Others neuromuscular blockade monitoring
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes total rocuronium dose administered during surgery to maintain moderate neuromuscular blockade at each measurement sites
Key secondary outcomes time to maximum block for an intubating dose, intubating conditions, lumbar retractor pressure, degree of lumbar muscle tension, overall surgical satisfaction score assessed by the surgeon and postoperative pain score

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 rocuronium-induced moderate neuromuscular blockade maintained based on acceleromyography at trapezius muscle
Interventions/Control_2 rocuronium-induced moderate neuromuscular blockade maintained based on acceleromyography at adductor pollicis muscle
Interventions/Control_3
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
75 years-old >=
Gender Male and Female
Key inclusion criteria patients who were scheduled to undergo elective lumbar spine surgery and had an American Society of Anesthesiologists physical status I or II
Key exclusion criteria Patients were excluded if they had a known hypersensitivity to the drugs used in this study, known neuromuscular disease, significant liver or renal dysfunction, cerebrovascular disease, or a body mass index >30.0 kg m-2. Patients who were required to perform intraoperative neurophysiological monitoring including motor evoked potential were also excluded.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Byung Gun
Middle name
Last name Lim
Organization Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea
Division name Department of Anaesthesiology and Pain Medicine
Zip code 08308
Address Korea University Guro Hospital, 148, Gurodong-ro, Guro-gu, Seoul 08308, Republic of Korea
TEL 82-2-2626-3231
Email bglim9205@korea.ac.kr

Public contact
Name of contact person
1st name Byung Gun
Middle name
Last name Lim
Organization Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea
Division name Department of Anaesthesiology and Pain Medicine
Zip code 08308
Address Korea University Guro Hospital, 148, Gurodong-ro, Guro-gu, Seoul 08308, Republic of Korea
TEL 82-2-2626-3231
Homepage URL
Email bglim9205@korea.ac.kr

Sponsor
Institute Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea
Institute
Department

Funding Source
Organization none
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 Korea University Guro Hospital Institutional Review Board, Seoul, Republic of Korea
Address Korea University Guro Hospital, 148, Gurodong-ro, Guro-gu, Seoul 08308, Republic of Korea
Tel 82-2-2626-1632
Email kughirb@naver.com

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 Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 01 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 50
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 Completed
Date of protocol fixation
2018 Year 05 Month 30 Day
Date of IRB
2018 Year 06 Month 27 Day
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 10 Month 16 Day
Last modified on
2019 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043664

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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