UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028151 |
|---|---|
| Receipt number | 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 07:24:33 |
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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
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
suguru-.-yamamoto@hotmail.co.jp
Sponsor or person
Institute
Department of anesthesiology, Ohkubo hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032220
