UMIN-CTR Clinical Trial

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
Last 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
Email	z250streetfighter@gmail.com

Public contact
1st 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
Email	z250streetfighter@gmail.com

Sponsor
Institute	Department of Anesthesiology, Kumamoto Central Hospital, Kumamoto, Japan
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	Kumamoto Central Hospital
Address	955 Muro, Ozu-machi Kikuchi-gun, Kumamoto
Tel	096-293-0555
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041368