UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of the influences of Sevoflurane or Desflurane on the postoperative state of pediatric general anesthesia
Title of the study (Brief title)	The influences of Sevoflurane and Desflurane on the postoperative state of pediatric general anesthesia
Region	Japan

Condition
Condition	pediatic surgery(inguinal hernia, umbilical hernia) otolaryngological surgery(tonsillar hypertrophy, adenoidal hypertrophy, otitis media)
Classification by specialty	Pediatrics Oto-rhino-laryngology Anesthesiology Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare Desflurane with Sevoflurane for the postoperative quality and possible side effects of pediatric general anesthesia
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Assessment of the quality during emergence period(agitation, nausea, vomiting)
Key secondary outcomes	Assessment of the quality at the point of one hour after returning the ward (agitation, nausea, vomiting)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	We randomly assign twenty children who undergo pediatric or otolaryngological surgery with 1-6% Sevoflurane at the induction and maintenance of anesthesia.
Interventions/Control_2	We randomly assign twenty children who undergo pediatric or otolaryngological surgery with 1-6% Sevoflurane at the induction and switched to 3-6% Desflurane at the maintenance of anesthesia.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	1 years-old <=
Age-upper limit	6 years-old >=
Gender	Male and Female
Key inclusion criteria	children 1-6 years old who receives an elective pediatric or otolaryngological surgery
Key exclusion criteria	ASA-PS(ASA physical status)>3 or 4, asthma, body weight>25kg
Target sample size	40

Research contact person
Name of lead principal investigator	Tomoaki Urabe
Organization	Hiroshima Prefectural Hospital
Division name	Anesthesiology
Address	1-5-54 Ujinakanda, Minamiku, Hiroshima-city, Hiroshima-prefecture, Japan 734-8530
TEL	082-3260-5203
Email	tomoakiurabe@gmail.com

Public contact
Name of contact person	Tomoaki Urabe
Organization	Hiroshima Prefectural Hospital
Division name	Anesthesiology
Address	1-5-54 Ujinakanda, Minamiku, Hiroshima-city, Hiroshima-prefecture, Japan 734-8530
TEL	082-254-1818
Homepage URL
Email	t-yoshimura87638@pref.hiroshima.lg.jp

Sponsor
Institute	Hiroshima Prefectural Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
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	県立広島病院　手術室（広島県）

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 30 Day
Anticipated trial start date	2015 Year 07 Month 01 Day
Last follow-up date	2015 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 17 Day
Last modified on	2016 Year 06 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020762