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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010545
Receipt No. R000012331
Scientific Title The deep hypnotic state of bispectral index values lower than 40 definitely attenuates rocuronium-induced withdrawal movement in children
Date of disclosure of the study information 2013/04/19
Last modified on 2013/10/21

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Basic information
Public title The deep hypnotic state of bispectral index values lower than 40 definitely attenuates rocuronium-induced withdrawal movement in children
Acronym The deep hypnotic state reduces withdrawal caused by rocuronium in children
Scientific Title The deep hypnotic state of bispectral index values lower than 40 definitely attenuates rocuronium-induced withdrawal movement in children
Scientific Title:Acronym The deep hypnotic state reduces withdrawal caused by rocuronium in children
Region
Asia(except Japan)

Condition
Condition minor elective surgery
Classification by specialty
Anesthesiology Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aims of this study are to evaluate whether it is possible for the deep hypnotic state of bispectral index (BIS) values lower than 40 to reduce the rocuronium-induced withdrawal movements and to determine the utility of BIS monitoring for preventing the withdrawal movements.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The incidence and grade of rocuronium-induced withdrawal movement
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Rocuronium is administered at the loss of eyelash reflex
Interventions/Control_2 Rocuronium is administered at the time of BIS under 40
Interventions/Control_3 Rocuronium is administered at the time of BIS under 40 after manual ventilation is provided with a tidal volume of 6-8 ml/kg using sevoflurane 8% at a fresh gas flow of O2 6 L/min
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
3 years-old <=
Age-upper limit
12 years-old >=
Gender Male and Female
Key inclusion criteria Pediatric patients aged 3~12 years with a physical status of 1 (the American Society of Anesthesiologists rating) who are scheduled to undergo minor elective surgery
Key exclusion criteria Patients with a history of cardiovascular, respiratory (asthma), neurologic (seizure), kidney, liver disease, mood disorder, prematurity, or developmental delay, the presence of upper respiratory infection, hypersensitivity to drugs, and those receiving analgesics, sedatives or psychiatric medication will be excluded. Patients with a vein that does not drain well or with redness, swelling and tenderness along the vein, and patients who had a history of difficult peripheral venous cannulation will be also excluded.
Target sample size 156

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Byung Gun Lim
Organization Guro Hospital, Korea University College of Medicine
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address 148 Gurodong-ro, Guro-gu, Seoul, Korea
TEL 82-2-2626-1437
Email bglim9205@korea.ac.kr

Public contact
Name of contact person
1st name
Middle name
Last name Byung Gun Lim
Organization Guro Hospital, Korea University College of Medicine
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address 148 Gurodong-ro, Guro-gu, Seoul, Korea
TEL 82-2-2626-1437
Homepage URL
Email bglim9205@korea.ac.kr

Sponsor
Institute Korea University
Institute
Department

Funding Source
Organization Korea University
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 19 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 Completed
Date of protocol fixation
2013 Year 04 Month 08 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 19 Day
Last follow-up date
Date of closure to data entry
2013 Year 05 Month 30 Day
Date trial data considered complete
2013 Year 06 Month 02 Day
Date analysis concluded
2013 Year 06 Month 03 Day

Other
Other related information

Management information
Registered date
2013 Year 04 Month 19 Day
Last modified on
2013 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012331

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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