UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036303 |
|---|---|
| Receipt number | R000041368 |
| Scientific Title | The Relationship between Dose of Fentanyl and Postoperative Nausea and Vomiting in Patients with Fentanyl-based Intravenous Patient-controlled Analgesia: A Retrospective Cohort Study with 450 Patients |
| Date of disclosure of the study information | 2019/03/27 |
| Last modified on | 2019/03/27 09:40:37 |
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Basic information
Public title
The Relationship between Dose of Fentanyl and Postoperative Nausea and Vomiting in Patients with Fentanyl-based Intravenous Patient-controlled Analgesia: A Retrospective Cohort Study with 450 Patients
Acronym
The Relationship between Dose of Fentanyl and Postoperative Nausea and Vomiting in Patients with Fentanyl-based Intravenous Patient-controlled Analgesia
Scientific Title
The Relationship between Dose of Fentanyl and Postoperative Nausea and Vomiting in Patients with Fentanyl-based Intravenous Patient-controlled Analgesia: A Retrospective Cohort Study with 450 Patients
Scientific Title:Acronym
The Relationship between Dose of Fentanyl and Postoperative Nausea and Vomiting in Patients with Fentanyl-based Intravenous Patient-controlled Analgesia
Region
| Japan |
Condition
Condition
Patients who received IV-PCA following a spine surgery or an upper limb surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Postoperative nausea and vomiting (PONV) is a common adverse event in patients with fentanyl-based intravenous patient-controlled analgesia (IV-PCA). This study was undertaken to evaluate the relationship between the dose of fentanyl and PONV in patients with IV-PCA.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Postoperative nausea and vomiting observed within 48 hours after the orthopedic surgical procedure
Key secondary outcomes
Age, gender, BMI, alcohol drinking status, smoking status, surgical duration, anesthesia duration, intraoperative fentanyl and remifentanil dose, and postoperative fentanyl concentration were analysed between PONV patients and non-PONV patients.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who received IV-PCA following a spine surgery or an upper limb surgery between January 2012 and September 2018 were eligible for this study.
Key exclusion criteria
Patients who did not receive IV-PCA following a spine surgery or an upper limb surgery between January 2012 and September 2018 were not eligible for this study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | ATSUSHI |
| Middle name | |
| Last name | KOTERA |
Organization
Kumamoto Central Hospital
Division name
Department of anesthesiology
Zip code
869-1235
Address
955 Muro, Ozu-machi Kikuchi-gun, Kumamoto
TEL
096-293-0555
z250streetfighter@gmail.com
Public contact
Name of contact person
| 1st name | ATSUSHI |
| Middle name | |
| Last name | KOTERA |
Organization
Kumamoto Central Hospital
Division name
Department of anesthesiology
Zip code
869-1235
Address
955 Muro, Ozu-machi Kikuchi-gun, Kumamoto
TEL
096-293-0555
Homepage URL
z250streetfighter@gmail.com
Sponsor or person
Institute
Department of Anesthesiology, Kumamoto Central Hospital, Kumamoto, Japan
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
Kumamoto Central Hospital
Address
955 Muro, Ozu-machi Kikuchi-gun, Kumamoto
Tel
096-293-0555
z250streetfighter@gmail.com
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
| 2019 | Year | 03 | Month | 27 | 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
450
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
Completed
Date of protocol fixation
| 2018 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All statistical analyses were carried out using the software program Excel Tokei 2012. Univariate analysis with the Mann-Whitney U-test was used to test for differences in continuous variables. In addition, multivariate logistic regression analysis was performed.
Management information
Registered date
| 2019 | Year | 03 | Month | 27 | Day |
Last modified on
| 2019 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041368
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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