UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Desflurane compared with sevoflurane on awakeing and quality of recovery in gynecological sugery: a randomized, double-blinded controlled trial
Title of the study (Brief title)	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	Eri Ashikari
Organization	Ohkubo hospital
Division name	department of anesthesiology
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	Suguru Yamamoto
Organization	Ohkubo hospital
Division name	department of anesthesiology
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 03 Month 31 Day
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

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Publication of results	Unpublished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