UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of a novel method of anesthesia combining propofol and volatile anesthesia on the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic gynecological surgery
Title of the study (Brief title)	Effects of a novel method of anesthesia combining propofol and volatile anesthesia on the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic gynecological surgery
Region	Japan

Condition
Condition	Patients scheduled for elective laparoscopic gynecological surgery
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate the effects of a novel method of anesthesia combining propofol and volatile anesthesia on the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic gynecological surgery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Complete response (no postoperative nausea and vomiting and no rescue antiemetic use) rate within 24 h of surgery
Key secondary outcomes	Incidence of nausea and vomiting Nausea severity score Vomiting frequency Rescue antiemetic use Postoperative pain

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	In the sevoflurane/propofol group, anesthesia is maintained with combined propofol and sevoflurane.
Interventions/Control_2	In the sevoflurane group, anesthesia is maintained with sevoflurane.
Interventions/Control_3	In the propofol group, anesthesia was maintained with an infusion of propofol.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Patients scheduled for elective laparoscopic gynecological surgery under general endotracheal anesthesia, with an American Society of Anesthesiologists (ASA) physical status of I and II.
Key exclusion criteria	Obesity (body mass index > 33 kg/m2) Neurological, renal, or liver disease Use of drugs with antiemetic properties,including corticosteroids
Target sample size	130

Research contact person
Name of lead principal investigator	Hiroaki Kawano
Organization	Tokushima Prefectural Central Hospital
Division name	Department of Anesthesiology
Address	1-10-3 Kuramoto, Tokushima 770-8539, Japan
TEL	088-633-7151
Email	hir.kawano@gmail.com

Public contact
Name of contact person	Hiroaki Kawano
Organization	Tokushima Prefectural Central Hospital
Division name	Department of Anesthesiology
Address	1-10-3 Kuramoto, Tokushima 770-8539, Japan
TEL	088-633-7151
Homepage URL
Email	hir.kawano@gmail.com

Sponsor
Institute	Department of Anesthesiology, Tokushima University Hospita
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	徳島大学病院

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 12 Month 01 Day
Anticipated trial start date	2009 Year 02 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 01 Month 01 Day
Last modified on	2016 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014890