UMIN-CTR Clinical Trial

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