UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of dexmedetomidine and fentanyl on emergence agitation after sevoflurane anesthesia in children undergoing adenotonsillectomy
Title of the study (Brief title)	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	Byung Gun Lim
Organization	Korea University Guro Hospital, Korea University College of Medicine
Division name	Department of Anesthesiology and Pain Medicine
Address	148 Gurodong-ro, Guro-gu, Seoul, Korea
TEL	82-2-2626-1437
Email	bglim9205@korea.ac.kr

Public contact
Name of contact person	Byung Gun Lim
Organization	Korea University Guro Hospital, Korea University College of Medicine
Division name	Department of Anesthesiology and Pain Medicine
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 03 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015627