UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020043 |
|---|---|
| Receipt number | R000023115 |
| Scientific Title | Effect of Acetaminophen in preventing postoperative shivering: A randomized, triple-blind, placebo-controlled study |
| Date of disclosure of the study information | 2015/12/02 |
| Last modified on | 2017/12/02 09:13:18 |
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Basic information
Public title
Effect of Acetaminophen in preventing postoperative shivering: A randomized, triple-blind, placebo-controlled study
Acronym
Effect of Acetaminophen in preventing postoperative shivering: A randomized, triple-blind, placebo-controlled study
Scientific Title
Effect of Acetaminophen in preventing postoperative shivering: A randomized, triple-blind, placebo-controlled study
Scientific Title:Acronym
Effect of Acetaminophen in preventing postoperative shivering: A randomized, triple-blind, placebo-controlled study
Region
| Japan |
Condition
Condition
Patients who will have elective gynecologic surgery
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate an effect of Acetaminophen to prevent postoperative shivering
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of postoperative shivering
Key secondary outcomes
The score of postoperative shivering
The change of intraoperative and postoperative core temperature
The incidence of postoperative nausea and vomitting
The values of pain intensity measured on visual analog scales
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
An administration of Acetaminophen
dose: 15 mg/kg (max 1000 mg)
duration of administration: 15 minutes
timing: Primary dosage is performed just after an anesthetic induction. Secondary dosage is performed after 4 hours.
Interventions/Control_2
An administration of Saline
dose: 1.5 ml/kg (max 100 ml)
duration of administration: 15 minutes
timing: Primary dosage is performed just after an anesthetic induction. Secondary dosage is performed after 4 hours.
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
Female
Key inclusion criteria
Patients who will have elective, gynecologic abdominal surgery
Predicted surgical time is over 2 hour
Patients' physical status(ASA) are 1 or 2
Patients without an impaired liver function
Patients without disturbance of consciousness
Key exclusion criteria
Insufficient record and measurement
Patients who refuse to participate this study
Patient with suspicion of allergy of Acetaminophen
Patient with acute toxicity of Lidocaine or Ropivacaine
Patient require critical care and mechanical ventilation in ICU after surgery
Patient who is determined to be excluded from the study due to any reason by the study doctor
Target sample size
96
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Kakinohana |
Organization
University of the Ryukyus
Division name
Department of Anesthesiology, Faculty of Medicine
Zip code
Address
Uehara 207 banchi, Nishihara-cho Nakagami-gun, Okinawa
TEL
0988952221
anesthks@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Tadokoro |
Organization
University of the Ryukyus
Division name
Department of Anesthesiology, Faculty of Medicine
Zip code
Address
Uehara 207 banchi, Nishihara-cho Nakagami-gun, Okinawa
TEL
0988952221
Homepage URL
rover2727@yahoo.co.jp
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 12 | Month | 02 | 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
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 02 | Day |
Last modified on
| 2017 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023115
| 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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