UMIN-CTR Clinical Trial

Basic information
Public title	Does longer postoperative oxygen administration reduce post-operative nausea and vomiting (PONV) for patients undergoing gynecological laparoscopic surgery?
Acronym	Does longer postoperative oxygen administration reduce post-operative nausea and vomiting (PONV) for patients undergoing gynecological laparoscopic surgery?
Scientific Title	Does longer postoperative oxygen administration reduce post-operative nausea and vomiting (PONV) for patients undergoing gynecological laparoscopic surgery?
Scientific Title:Acronym	Does longer postoperative oxygen administration reduce post-operative nausea and vomiting (PONV) for patients undergoing gynecological laparoscopic surgery?
Region	Japan

Condition
Condition	Patients undergoing laparoscopic gynecological surgery
Classification by specialty	Obsterics and gynecology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To demonstrate if longer postoperative oxygen administration reduces PONV.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Reduction of PONV incidence
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	postoperative oxygen administration 2L/min with nasal cannula for one hour.
Interventions/Control_2	postoperative oxygen administration 2L/min with nasal cannula for five hours.
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	Not applicable
Age-upper limit	60 years-old >=
Gender	Female
Key inclusion criteria	Female patient undergoing laparoscopic gynecological surgery
Key exclusion criteria	Patients do not receive total intravenous anesthesia. Patients whom investigators consider to be ineligible
Target sample size	1000

Research contact person
Last name of lead principal investigator	1st name Middle name Last name TAKEHIKO NAGAOKA
Organization	Shin-yurigaoka general hospital
Division name	Anesthesia
Zip code
Address	255 furusawa-toko, Asao, Kawasaki, Kanagawa
TEL	0443229991
Email	takeitezzz@gmail.com

Public contact
1st name of contact person	1st name Middle name Last name TAKEHIKO NAGAOKA
Organization	Shin-yurigaoka General Hospital
Division name	Anesthesia
Zip code
Address	255 furusawa-toko, Asao, Kawasaki, Kanagawa
TEL	0443229991
Homepage URL
Email	takeitezzz@gmail.com

Sponsor
Institute	Shin-yurigaoka general hospital
Institute
Department

Funding Source
Organization	Our institute
Organization
Division
Category of Funding Organization	Other
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 05 Month 31 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	Enrolling by invitation
Date of protocol fixation	2015 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 04 Month 10 Day
Last modified on	2019 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025198