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Name
UMIN ID

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013394
Receipt No. R000015627
Scientific Title The effects of dexmedetomidine and fentanyl on emergence agitation after sevoflurane anesthesia in children undergoing adenotonsillectomy
Date of disclosure of the study information 2014/03/11
Last modified on 2018/09/13

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Basic information
Public title The effects of dexmedetomidine and fentanyl on emergence agitation after sevoflurane anesthesia in children undergoing adenotonsillectomy
Acronym The effects of dexmedetomidine and fentanyl on emergence agitation in children
Scientific Title The effects of dexmedetomidine and fentanyl on emergence agitation after sevoflurane anesthesia in children undergoing adenotonsillectomy
Scientific Title:Acronym The effects of dexmedetomidine and fentanyl on emergence agitation in children
Region
Asia(except Japan)

Condition
Condition Adenotonsillectomy
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to investigate the effects of dexmedetomidine and fentanyl on emergence agitation after sevoflurane anesthesia in children undergoing adenotonsillectomy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Emergence agitation score (using both a 5-point sacle and a PAED scale)
Key secondary outcomes Hemodynamics including mean blood pressure and heart rate, recovery profiles including the time to restration of self-respiration, eye opening on verbal command, and extubation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Control group will be infused with normal saline 10 ml throughout 10 min 6 min before anesthesia induction.
Interventions/Control_2 Dexmedetomidine group will be infused with dexmedetomidine 2 mcg/kg + normal saline (total 10 ml) throughout 10 min 6 min before anesthesia induction.
Interventions/Control_3 Fentanyl group will be infused with fentanyl 2 mcg/kg + normal saline (total 10 ml) throughout 10 min 6 min before anesthesia induction.
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 adenotonsillectomy.
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 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Byung Gun Lim
Organization Korea University 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 Korea University 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
2014 Year 03 Month 11 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 Terminated
Date of protocol fixation
2014 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 03 Month 11 Day
Last modified on
2018 Year 09 Month 13 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015627

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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