UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031024 |
|---|---|
| Receipt number | R000035422 |
| Scientific Title | Determination of risk factor of new onset shivering after neurosurgery. |
| Date of disclosure of the study information | 2018/01/26 |
| Last modified on | 2018/01/26 21:21:06 |
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Basic information
Public title
Determination of risk factor of new onset shivering after neurosurgery.
Acronym
Determination of risk factor of new onset shivering after neurosurgery.
Scientific Title
Determination of risk factor of new onset shivering after neurosurgery.
Scientific Title:Acronym
Determination of risk factor of new onset shivering after neurosurgery.
Region
| Japan |
Condition
Condition
Neurosurgical patients who underwent a craniotomy operation
Classification by specialty
| Neurosurgery | Intensive care medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Shivering after neurosurgery is common but undesirable because it increases oxygen consumption and intracranial pressure.1) Although past investigations identified several risk factors of shivering, 2) the role of intraoperative narcotics remains unclear. Because anesthesia for neurosurgery often involves fentanyl or remifentanil-based techniques, it is conceivable that narcotics induce acute tolerance and subsequent withdrawal symptoms including shivering when they are discontinued at the end of surgery. Conversely, the proper use of narcotics may prevent shivering. 3) The purpose of this study was to investigate whether the amount of intraoperative narcotics affects the occurrence of shivering at the end of neurosurgical operations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the occurrence of shivering at the end of neurosurgical operations.
Key secondary outcomes
the length of hospital stay, ICU stay and high care unit stay.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. operation under general anesthesia
2. operation serection:craniotomy for tumor or hemangioma, brain artery clipping surgery
3. operation duration over 6hours
4. extubation in the operating room
Key exclusion criteria
1. administration of pethidine before extubation or after leaving operating room
2. any other reasons, inappropriate for the serection assessed by the doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takako Hamada |
Organization
Department of Intensive Care Unit Yokohama City University.
Division name
Department of Intensive Care Unit
Zip code
Address
Fukuura 3-9 Kanazawa-ku Yokohama-city Kanagawa Japan
TEL
045-787-2800
hamadatakakohamachan@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takako Hamada |
Organization
Department of Intensive Care Unit Yokohama City University.
Division name
Department of Intensive Care Unit
Zip code
Address
Fukuura 3-9 Kanazawa-ku Yokohama-city Kanagawa Japan
TEL
045-787-2800
Homepage URL
hamadatakakohamachan@gmail.com
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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 | 01 | Month | 26 | 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
| 2016 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Perioperative information was extracted from electrical health record and analyzed using unpaired t tests and multivariable logistic regression.
Patients who met the criteria who underwent operation from January 2011 to September 2016.
Management information
Registered date
| 2018 | Year | 01 | Month | 26 | Day |
Last modified on
| 2018 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035422
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
