UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010599 |
|---|---|
| Receipt number | 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 15:55:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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 | 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012387
