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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008532
Receipt No. R000010034
Scientific Title Parecoxib and postoperative shivering in patients undergoing general anesthesia.
Date of disclosure of the study information 2012/07/25
Last modified on 2013/12/09

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Basic information
Public title Parecoxib and postoperative shivering in patients undergoing general anesthesia.
Acronym Parecoxib and shivering
Scientific Title Parecoxib and postoperative shivering in patients undergoing general anesthesia.
Scientific Title:Acronym Parecoxib and shivering
Region
Asia(except Japan)

Condition
Condition patients undergoing general anesthesia were recruited into the study
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of parecoxib administered intraoperatively on postoperative shivering
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the overall incidence and grades of postoperative shivering
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 In group P, intravenous parecoxib (40mg) was given following the induction of anesthesia.
Interventions/Control_2 In group S, patients recived the same amount of saline 0.9% infusion.
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
60 years-old >=
Gender Male and Female
Key inclusion criteria adult patients (ASA physical status I or II) scheduled for elective minor urological surgery under general anesthetic with no prior medication were included in this study
Key exclusion criteria 1, initial body temperature more than 38 centigrade or less than 36.5 centigrade;
2, hyperthyroidism, hypertension, diabetes mellitus, impaired renal or liver functions, endocrine or cardiopulmonary disease;
3, taking vasoactive or antidepressant drugs, receiving intraoperative blood or blood products transfusion;
4, known history of alcohol or substance abuse, or possible pregnancy;
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chen Jie
Organization Third Military Medical University
Division name Department of Anaesthesiology, Southwest Hospital,
Zip code
Address Gaotanyan road, Shapingba, Chongqing, China
TEL +81-086-23-68754197
Email cjandsh2009@yahoo.cn

Public contact
Name of contact person
1st name
Middle name
Last name Chen Jie
Organization Third Military Medical University
Division name Department of Anaesthesiology, Southwest Hospital,
Zip code
Address Gaotanyan road, Shapingba, Chongqing, China
TEL +81-086-23-68754197
Homepage URL
Email cjandsh2009@yahoo.cn

Sponsor
Institute Department of Anaesthesiology, Southwest Hospital,
Institute
Department

Funding Source
Organization Department of Anaesthesiology, Southwest Hospital,
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
Email

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
2012 Year 07 Month 25 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
2012 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 07 Month 25 Day
Last modified on
2013 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010034

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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