UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048235 |
|---|---|
| Receipt number | R000054922 |
| Scientific Title | Postoperative nausea A study to investigate the factors responsible for vomiting |
| Date of disclosure of the study information | 2022/07/02 |
| Last modified on | 2022/07/10 10:54:47 |
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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
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
tyinnagoyauniversity@gmail.com
Sponsor or person
Institute
Ogaki Municipal Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054922
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