UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002875 |
|---|---|
| Receipt number | R000003502 |
| Scientific Title | Effects of anesthetics on changes in intraocular pressure during prone surgery |
| Date of disclosure of the study information | 2009/12/11 |
| Last modified on | 2015/11/24 16:37:00 |
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Basic information
Public title
Effects of anesthetics on changes in intraocular pressure during prone surgery
Acronym
IOPAP
(Intraocular pressure and anesthetics during prone surgery)
Scientific Title
Effects of anesthetics on changes in intraocular pressure during prone surgery
Scientific Title:Acronym
IOPAP
(Intraocular pressure and anesthetics during prone surgery)
Region
| Japan |
Condition
Condition
Spine desease
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the effects of anesthetic agents on intraocular pressure during prone position.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
intraocular pressure
Key secondary outcomes
Incidence of postoperative ophthalmological dysfunction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sevoflurane anesthesia(+)
Propofol anesthesia(-)
Interventions/Control_2
Sevoflurane anesthesia(-)
Propofol anesthesia(+)
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Prone position
Key exclusion criteria
preoperative ophthalmological complication
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Kawaguchi |
Organization
Nara Medical University
Division name
Department of Anesthesiology
Zip code
Address
840 shijo-cho, Kashihara, Nara, Japan
TEL
+81-744-29-8902
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Kawaguchi |
Organization
Nara Medical University
Division name
Department of Anesthesiology
Zip code
Address
840 shijo-cho, Kashihara, Nara, Japan
TEL
+81-744-29-8902
Homepage URL
drjkawa@naramed-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Nara Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
奈良県立医科大学付属病院（奈良県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We investigated change of intraocular pressure (IOP) under propofol and sevoflurane anesthesia during prone position . IOP values after positioning in the prone position were significantly higher than those at baseline in both groups. Although IOP values were higher in the sevoflurane group than in the propofol group, the differences in IOP values were not statistically significant.
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
| 2008 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 11 | Day |
Last modified on
| 2015 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003502
| Research Plan | |
|---|---|
| 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 |
