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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023647
Receipt No. 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

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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
Obsterics 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
Email 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
Email yukauma923@gmail.com

Sponsor
Institute Hakodate central general hospital
Institute
Department

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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027236

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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