UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010545 |
|---|---|
| Receipt number | 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 12:35:04 |
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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
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
bglim9205@korea.ac.kr
Sponsor or person
Institute
Korea University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012331
