UMIN-CTR Clinical Trial

Basic information
Public title	Risk factors for postoperative nausea and vomiting in patients who underwent catheter ablation
Acronym	Risk factors for postoperative nausea and vomiting in patients who underwent catheter ablation
Scientific Title	Risk factors for postoperative nausea and vomiting in patients who underwent catheter ablation
Scientific Title:Acronym	Risk factors for postoperative nausea and vomiting in patients who underwent catheter ablation
Region	Japan

Condition
Condition	patients who underwent catheter ablation in operation rooom
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Cases in which ablation has been performed in the operating room will be selected. Among the selected cases, we will divide them into two groups, PONV and non-PONV, and study the perioperative factors.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Investigate risk factors for the development of PONV within 24 hours after ablation surgery
Key secondary outcomes	Identify the relationship between PONV and health care resources, including length of stay, within 24 hours after surgery

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	18 years-old <
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients who underwent ablation 2) Patients under general anesthesia for the above operations 3) Age: 18 years and older 4) Gender: any gender 5) By inpatient/outpatient category: inpatients 6) No questions about the American Society of Anesthesiologists (ASA) systemic classification.
Key exclusion criteria	1) Patients with communication difficulties due to dementia, mental illness, etc. 2) Emergency surgery cases 3) Cases in which extubation was not performed in the operating room 4) Other patients whose participation in the study is judged to be problematic by the principal investigator or research co-investigator.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Yoshinori Middle name Last name Tanigawa
Organization	Saga University Hospital
Division name	Anesthesiology and Critical Care Medicins
Zip code	849-8501
Address	5-1-1, Nabeshima-cho, Saga City, Saga Prefecture
TEL	0952343370
Email	e6580@cc.saga-u.ac.jp

Public contact
Name of contact person	1st name Yoshinori Middle name Last name Tanigawa
Organization	Saga University Hospital
Division name	Anesthesiology and Critical Care Medicins
Zip code	849-8501
Address	5-1-1, Nabeshima-cho, Saga City, Saga Prefecture
TEL	0952343370
Homepage URL
Email	e6580@cc.saga-u.ac.jp

Sponsor
Institute	Saga University Hospital
Institute
Department

Funding Source
Organization	Saga University Hospital
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	Saga University Hospital
Address	5-1-1, Nabeshima-cho, Saga City, Saga Prefecture
Tel	0952343400
Email	e6580@cc.saga-u.ac.jp

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	2020 Year 12 Month 01 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	Preinitiation
Date of protocol fixation	2020 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date	2020 Year 12 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	observational study

Management information
Registered date	2020 Year 09 Month 28 Day
Last modified on	2020 Year 09 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047845