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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010599
Receipt No. R000012387
Scientific Title The surgical pleth index-guided analgesia enhances postoperative pain and emergence agitation, resulting in increased analgesic requirement compared with the conventional practice analgesia in children
Date of disclosure of the study information 2013/04/26
Last modified on 2014/11/08

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Basic information
Public title The surgical pleth index-guided analgesia enhances postoperative pain and emergence agitation, resulting in increased analgesic requirement compared with the conventional practice analgesia in children
Acronym The surgical pleth index-guided analgesia compared with the conventional practice analgesia in children
Scientific Title The surgical pleth index-guided analgesia enhances postoperative pain and emergence agitation, resulting in increased analgesic requirement compared with the conventional practice analgesia in children
Scientific Title:Acronym The surgical pleth index-guided analgesia compared with the conventional practice analgesia in children
Region
Asia(except Japan)

Condition
Condition elective tonsillectomy and adenoidectomy
Classification by specialty
Anesthesiology Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aims of this study are to evaluate the effectiveness of surgical pleth index-guided analgesia compared with conventional practice analgesia in the aspects of intraoperative anesthetic and analgesic requirement, hemodynamic change, recovery profiles and postoperative pain, analgesic requirement and emergence agitation in children.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Intraoperative analgesic requirement
Key secondary outcomes Intraoperative anesthetic consumption, hemodynamics, recovery profiles, and postoperative pain, analgesic requirement and emergence agitation

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
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Fentanyl 0.5 mcg/kg will be administered when surgical pleth index (SPI) value is above 50 in SPI group for 3-5 min.
Interventions/Control_2 Fentanyl 0.5 mcg/kg will be administered when blood pressure or heart rate is increased to above 20% of the baseline value in control group for 3-5 min.
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
3 years-old <=
Age-upper limit
10 years-old >=
Gender Male and Female
Key inclusion criteria Pediatric patients aged 3~10 years with a physical status of 1 (the American Society of Anesthesiologists rating) who are scheduled to undergo elective tonsillectomy and adenoidectomy.
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.
Target sample size 50

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@hanmail.net

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 26 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 03 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 26 Day
Last follow-up date
Date of closure to data entry
2013 Year 06 Month 28 Day
Date trial data considered complete
2013 Year 06 Month 29 Day
Date analysis concluded
2013 Year 07 Month 05 Day

Other
Other related information

Management information
Registered date
2013 Year 04 Month 26 Day
Last modified on
2014 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012387

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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