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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028151
Receipt No. R000032220
Scientific Title Desflurane compared with sevoflurane on awakeing and quality of recovery in gynecological sugery: a randomized, double-blinded controlled trial
Date of disclosure of the study information 2017/07/10
Last modified on 2017/07/18

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Basic information
Public title Desflurane compared with sevoflurane on awakeing and quality of recovery in gynecological sugery: a randomized, double-blinded controlled trial
Acronym Desflurane compared with sevoflurane on awakeing and quality of recovery in gynecological sugery
Scientific Title Desflurane compared with sevoflurane on awakeing and quality of recovery in gynecological sugery: a randomized, double-blinded controlled trial
Scientific Title:Acronym Desflurane compared with sevoflurane on awakeing and quality of recovery in gynecological sugery
Region
Japan

Condition
Condition cervical polyps
myoma of the uterus
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 improvement of awaking and quality of recovery from anesthesia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes time to awaking from discontinuation of anesthesia
Key secondary outcomes post anesthetic complications

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 During operations, anesthesia maintenance was achieved using 3% desflurane for cases . At the end of operations, the anesthetic agent is discontinued.
Interventions/Control_2 During operations, anesthesia maintenance was achieved using 1.25% sevoflurane for controls . At the end of operations, the anesthetic agent is discontinued.
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
20 years-old <=
Age-upper limit
50 years-old >
Gender Female
Key inclusion criteria study-eligible subjects are ASA PS 1 or 2 women undergoing trans cervical resection (TCR).
Key exclusion criteria obese patients whose BMI is 30 or more, or subjects taking central nervous system depressants
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eri Ashikari
Organization Ohkubo hospital
Division name department of anesthesiology
Zip code
Address 2-44-1, Kabuki-chou, Shinjuku-ku, Tokyo
TEL 03-5273-7711
Email eri_ashikari@tokyo-hmt.jp

Public contact
Name of contact person
1st name
Middle name
Last name Suguru Yamamoto
Organization Ohkubo hospital
Division name department of anesthesiology
Zip code
Address 2-44-1, Kabuki-chou, Shinjuku-ku, Tokyo
TEL 03-5273-7711
Homepage URL
Email suguru-.-yamamoto@hotmail.co.jp

Sponsor
Institute Department of anesthesiology, Ohkubo hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 10 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 No longer recruiting
Date of protocol fixation
2017 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 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
2017 Year 07 Month 09 Day
Last modified on
2017 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032220

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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