UMIN-CTR Clinical Trial

Basic information
Public title	Examine risk factors for PONV (postoperative nausea and vomiting).
Acronym	Exploratory study of risk factors for PONV
Scientific Title	Postoperative nausea A study to investigate the factors responsible for vomiting
Scientific Title:Acronym	Postoperative nausea Investigate the causes of vomiting
Region	Japan

Condition
Condition	postoperative nausea and vomiting
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The Japanese version of HADS, which evaluates anxiety and depression, can be a useful factor in creating a highly accurate PONV prediction model by preoperatively evaluating the occurrence of PONV and verifying factors involved in PONV. Consider things exploratory.
Basic objectives2	Others
Basic objectives -Others	Compare the predictive model including the Japanese version of HADS with the existing predictive model to verify whether a highly accurate model can be created.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To investigate whether the Japanese version of HADS evaluated before surgery causes postoperative PONV nausea and vomiting.
Key secondary outcomes	Patient information: age, gender, medical history, height, weight, drinking, smoking, PONV medical history, insomnia Surgical information: Surgical procedure, surgical time, anesthesia time, bleeding volume, fluid replacement volume, intraoperative drug usage, intraoperative BIS (Bispectral Index) Postoperative information: Opioid use, pain (NRS: Numerical Rating Scale), delirium (CAM-ICU), number of times metoclopramide is used

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients scheduled for thoracoscopic surgery in respiratory surgery Patients aged 20 years or older (no upper limit) at the time of enrollment
Key exclusion criteria	Patients who do not understand Japanese Patients with emergency surgery Patients with dizziness or nausea and vomiting due to underlying disease Patients with allergies to local anesthetics Patients with chest reoperation Patients who have undergone thoracotomy due to intraoperative findings Patients taking psychotropic drugs before surgery Other patients who are judged to be inappropriate by the doctor in charge of this research
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Tatsuro Middle name Last name Yokoyama
Organization	Ogaki Municipal Hospital
Division name	Anesthesiology
Zip code	503-8502
Address	4-86 Minaminokawa-cho, Ogaki City, Gifu Prefecture
TEL	0584-81-3341
Email	tyinnagoyauniversity@gmail.com

Public contact
Name of contact person	1st name Tatsuro Middle name Last name Yokoyama
Organization	Ogaki Municipal Hospital
Division name	Anesthesiology
Zip code	503-8502
Address	4-86 Minaminokawa-cho, Ogaki City, Gifu Prefecture
TEL	0584-81-3341
Homepage URL
Email	tyinnagoyauniversity@gmail.com

Sponsor
Institute	Ogaki Municipal 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)

IRB Contact (For public release)
Organization	Ogaki Municipal Hospital
Address	4-86 Minaminokawa-cho, Ogaki City, Gifu Prefecture
Tel	0584-81-3341
Email	clinical-trial@omh.ogaki.gifu.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	2022 Year 07 Month 02 Day

Related information
URL releasing protocol	Information other than the content described on this site is not open to the public
Publication of results	Unpublished

Result
URL related to results and publications	Information other than the content described on this site is not open to the public
Number of participants that the trial has enrolled	98
Results	The incidence of PONV was 22 (22.4%). Comparing the group with PONV and the group without PONV, the Anxiety score was 4.0 (2.0-7.0) vs 6.5 (4.0-9.8) and the Depression score was 4.0 (2.0-8.0) vs 6.0 (2.5-8.0). (median (quartiles: Q1-Q3))
Results date posted	2022 Year 07 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2022 Year 07 Month 02 Day
Baseline Characteristics	63 males and 35 females. The age was 72 (66.3-76.0) years, the height was 160.2 (155.3-166.2) cm, the weight was 59.2 (53.1-63.4) kg, and there were 62 smokers. A history of PONV was observed in 7 cases, and insomnia was observed in 39 cases. (median (quartiles: Q1-Q3))
Participant flow	A preoperative outpatient nurse conducted a questionnaire survey using the Japanese version of HADS. The results of the questionnaire in the preoperative outpatient department were not known to the anesthesia doctor in charge, the patient himself, or the nurse in charge, and were sealed in an envelope until 72 hours after the operation so that no one could see the results.　The anesthesia doctor in charge and the postoperative round anesthesia and surgical anesthesia nurses, and the ward nurses were blinded. Insomnia was interviewed on the morning of the day of surgery, and self-reported and classified into insomnia and no insomnia.
Adverse events	None
Outcome measures	PONV occurred in 22 cases (22.4%). The Anxiety score was 4.5 (2.0-7.8) points and the Depression score was 5.0 (2.0-8.0) points. The intraoperative fentanyl usage was 6.3 (4.9-7.4) mcg / kg, and 7 cases required postoperative fentanyl. The operation time was 125 (85.5-147.5) minutes, and the intraoperative replenishment volume was 17.6 (13.2-22.8) mL / kg. (median (quartiles: Q1-Q3))
Plan to share IPD	None
IPD sharing Plan description	None

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 02 Month 01 Day
Date of IRB	2019 Year 02 Month 28 Day
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date	2021 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

The Japanese version of HADS was used for patients scheduled for complete thoracoscopic surgery and thoracoscopic-assisted lung tumor resection at our institution's respiratory surgery between April 2019 and January 2021. A questionnaire survey was conducted preoperatively. The presence or absence of insomnia on the eve of surgery was investigated, and the presence or absence of nausea and vomiting was investigated within 72 hours after surgery.

Management information
Registered date	2022 Year 07 Month 02 Day
Last modified on	2022 Year 07 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054922