UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031457 |
|---|---|
| Receipt number | R000035875 |
| Scientific Title | Preventive effect of postoperative nausea and vomiting will be correlated with the dose of intraoperative acetaminophen : a randomized clinical trial about patients without pain |
| Date of disclosure of the study information | 2018/02/24 |
| Last modified on | 2023/08/30 11:55:15 |
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Basic information
Public title
Preventive effect of postoperative nausea and vomiting will be correlated with the dose of intraoperative acetaminophen : a randomized clinical trial about patients without pain
Acronym
Preventive effect of postoperative nausea and vomiting will be correlated with the dose of intraoperative acetaminophen : a randomized clinical trial about patients without pain
Scientific Title
Preventive effect of postoperative nausea and vomiting will be correlated with the dose of intraoperative acetaminophen : a randomized clinical trial about patients without pain
Scientific Title:Acronym
Preventive effect of postoperative nausea and vomiting will be correlated with the dose of intraoperative acetaminophen : a randomized clinical trial about patients without pain
Region
| Japan |
Condition
Condition
Orthopedic upper limb or leg disorders
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to verify the dose of intraoperative acetaminophen preventive effect of postoperative nausea and vomiting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative nausea and vomiting evaluation performed by numerical rating scale(NRS) after 30 minutes,2 hours,6 hours,24 hours postoperatively.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
intraoperative intravenous acetaminophen 15mg/kg
Interventions/Control_2
intraoperative intravenous acetaminophen 7.5mg/kg
Interventions/Control_3
intraoperative intravenous saline 100ml
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 of ASA 1-2 who are scheduled to undergo general-epidural anesthesia or general-conduction anesthesia in an operation of orthopedic upper limb or leg
Key exclusion criteria
patients with liver or kidney disfunction or dementia
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sakurako Ichinokawa |
Organization
National hospital organization Saitama hospital
Division name
Department of anesthesiology
Zip code
Address
2-1 Suwa, Wako-shi, Saitama
TEL
090-5437-0602
sakux3tto@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sakurako Ichinokawa |
Organization
National hospital organization Saitama hospital
Division name
Department of anesthesiology
Zip code
Address
2-1 Suwa, Wako-shi, Saitama
TEL
090-5437-0602
Homepage URL
sakux3tto@gmail.com
Sponsor or person
Institute
Department of anesthesiology,National hospital organization Saitama hospital
Institute
Department
Personal name
Funding Source
Organization
Department of anesthesiology,National hospital organization Saitama 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
Address
Tel
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
| 2018 | Year | 02 | Month | 24 | 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
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 24 | Day |
Last modified on
| 2023 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035875
