UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013549 |
|---|---|
| Receipt number | R000015189 |
| Scientific Title | Effect of peroperative low-dose naloxone infusion on the development of remifentanil-induced shivering.Randomized double-blind study |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2015/10/28 18:33:41 |
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Basic information
Public title
Effect of peroperative low-dose naloxone infusion on the development of remifentanil-induced shivering.Randomized double-blind study
Acronym
prevention of remifentanil-induced shivering by naloxone infusion
Scientific Title
Effect of peroperative low-dose naloxone infusion on the development of remifentanil-induced shivering.Randomized double-blind study
Scientific Title:Acronym
prevention of remifentanil-induced shivering by naloxone infusion
Region
| Japan |
Condition
Condition
patients who receives remifentanil based anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
prevention of remifentanil-induced shivering by naloxone
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
presence of shivering within 2 hours after emergence from remifentanil based ansethesai
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
patients who receives remifentanil and saline infusion
Interventions/Control_2
patients who receives remifentanil and naloxone 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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients both sex who receives remifentanil based anesthesia for laparoscopic or open laparotomy
Key exclusion criteria
patients with febrile symptom, aptients who is obese.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manzo Suzuki |
Organization
Nippon Medical School Musashikosugi Hospital
Division name
Anesthesiology
Zip code
Address
1-396 Kosugityou Nakaharaku Kawasaki
TEL
0447335181
manzo@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Manzo Suzuki |
Organization
Nippon Medical School Musashikosugi Hospital
Division name
Anesthesiology
Zip code
Address
1-396 Kosugityou Nakaharaku Kawasaki
TEL
0447335181
Homepage URL
manzo@nms.ac.jp
Sponsor or person
Institute
Department of Anesthesiology Musashikosugi-Hopaital Nippo Medical School
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
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
日本医科大学武蔵小杉病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 01 | 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 | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | 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
| 2014 | Year | 03 | Month | 28 | Day |
Last modified on
| 2015 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015189
