UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038309 |
|---|---|
| Receipt number | 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 11:12:02 |
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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
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
bglim9205@korea.ac.kr
Sponsor or person
Institute
Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043664
