UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Which provides better postoperative recovery in combined general/epidural anesthesia? Sefofulurane/propofol coadministration vs propofol: a randomized clinical trial.
Title of the study (Brief title)	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	Yuka Uchinami
Organization	Hakodate central general hospital
Division name	anesthesiology
Address	33-2 Honcho Hakodate Hokkaido Japan
TEL	0138-52-1231
Email	yukauma923@gmail.com

Public contact
Name of contact person	Uchinami Yuka
Organization	Hakodate central general hospital
Division name	anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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