UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017940
Receipt number R000020762
Scientific Title Comparison of the influences of Sevoflurane or Desflurane on the postoperative state of pediatric general anesthesia
Date of disclosure of the study information 2015/07/01
Last modified on 2016/06/17 09:24:09

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Basic information

Public title

Comparison of the influences of Sevoflurane or Desflurane on the postoperative state of pediatric general anesthesia

Acronym

The influences of Sevoflurane and Desflurane on the postoperative state of pediatric general anesthesia

Scientific Title

Comparison of the influences of Sevoflurane or Desflurane on the postoperative state of pediatric general anesthesia

Scientific Title:Acronym

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)


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



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

1st name
Middle name
Last name Tomoaki Urabe

Organization

Hiroshima Prefectural Hospital

Division name

Anesthesiology

Zip code


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

1st name
Middle name
Last name Tomoaki Urabe

Organization

Hiroshima Prefectural Hospital

Division name

Anesthesiology

Zip code


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 or person

Institute

Hiroshima Prefectural Hospital

Institute

Department

Personal name



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)



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

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


Related information

URL releasing protocol


Publication of results

Published


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

2015 Year 06 Month 30 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020762


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name