UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	postoperative nausea and vomiting after gynecologic hysteroscopic surgery on propofol and remifentanil total intravenous anesthesia (tiva) vs. desflurane and remifentanil anesthesia; prospective, randomized, double-blinded, control study
Title of the study (Brief title)	Comparing the effect on postoperative nausea and vomming, between propofol/remifentanil anesthesia and desuflurane/remifentanil anesthesia
Region	Japan

Condition
Condition	women who undertake hysteroscopic surgery
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	propofol/remifentanil anesthesia reduces the incidence and the degree of postoperative nausea and vommiting, compared with desflurane/remifentanil anesthesia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the incidence of post operative nausea and vomiting and the degree of it
Key secondary outcomes

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	general anesthesia with propofol/remifentanil TIVA
Interventions/Control_2	general anesthesia with Desflurane/remifentanil
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	ASA PS 1 or 2, non-pregnant female patients who undergo trans corporeal resection
Key exclusion criteria	BMI >=30 kg/m2, treated with psychoactive drags, too much alcohol intake, allergy with drags used in this study
Target sample size	70

Research contact person
Name of lead principal investigator	Suguru Yamamoto
Organization	Ohokubo Hospital
Division name	Anesthesiology
Address	2-44-1 Kabuki-cho, Shinjyuku-ku, Tokyo 160-8488 Japan
TEL	03-5273-7111
Email	suguru-.-yamamoto@hotmail.co.jp

Public contact
Name of contact person	Suguru Yamamoto
Organization	Ohokubo Hospital
Division name	Anesthesiology
Address	2-44-1 Kabuki-cho, Shinjyuku-ku, Tokyo 160-8488 Japan
TEL	03-5273-7111
Homepage URL
Email	suguru-.-yamamoto@hotmail.co.jp

Sponsor
Institute	Ohokubo Hospital IRB
Institute
Department

Funding Source
Organization	Ohokubo Hospital
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	2018 Year 10 Month 30 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 01 Month 31 Day
Anticipated trial start date	2018 Year 06 Month 20 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	2018 Year 10 Month 29 Day
Last modified on	2018 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037587