UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023647 |
|---|---|
| Receipt number | R000027236 |
| Scientific Title | Which provides better postoperative recovery in combined general/epidural anesthesia? Sefofulurane/propofol coadministration vs propofol: a randomized clinical trial. |
| Date of disclosure of the study information | 2016/08/16 |
| Last modified on | 2017/11/11 23:40:16 |
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Basic information
Public title
Which provides better postoperative recovery in combined general/epidural anesthesia? Sefofulurane/propofol coadministration vs propofol: a randomized clinical trial.
Acronym
Comparison Sefofulurane/propofol coadministration anesthesia with propofol anesthesia
Scientific Title
Which provides better postoperative recovery in combined general/epidural anesthesia? Sefofulurane/propofol coadministration vs propofol: a randomized clinical trial.
Scientific Title:Acronym
Comparison Sefofulurane/propofol coadministration anesthesia with propofol anesthesia
Region
| Japan |
Condition
Condition
gynecology
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the effects of a propofol/sevoflurane maintenance regimen with that of a propofol regimen on recovery profiles
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence of postoperative nausea and vomitting
Key secondary outcomes
Awaking time, cough score, emergence agitation score, incidence of postoperative nausea and vomittingQoL recovery score
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
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sevoflurane/propofol coadministration anesthesial
Interventions/Control_2
propofol 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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
elective laparoscopic surgery of gynecological benign disease, ASA1,2, combined general/epidural anesthesia
Key exclusion criteria
cognitive impairment, Migrating to abdominal surgery, history of malignant hyperthermia, pregnant, invalid case of epidural anesthesia, questionnaire cannot be collected
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuka Uchinami |
Organization
Hakodate central general hospital
Division name
anesthesiology
Zip code
Address
33-2 Honcho Hakodate Hokkaido Japan
TEL
0138-52-1231
yukauma923@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Uchinami Yuka |
Organization
Hakodate central general hospital
Division name
anesthesiology
Zip code
Address
33-2 Honcho Hakodate Hokkaido Japan
TEL
0138-52-1231
Homepage URL
yukauma923@gmail.com
Sponsor or person
Institute
Hakodate central general 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
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
| 2016 | Year | 08 | Month | 16 | 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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 16 | Day |
Last modified on
| 2017 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027236
