UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020241 |
|---|---|
| Receipt number | R000023372 |
| Scientific Title | The effect of nitrous oxide on the ocular pressure under remifentanil and sevoflurane anesthesia |
| Date of disclosure of the study information | 2015/12/17 |
| Last modified on | 2015/12/17 10:43:09 |
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Basic information
Public title
The effect of nitrous oxide on the ocular pressure under remifentanil and sevoflurane anesthesia
Acronym
The effect of nitrous oxide on the ocular pressure under remifentanil and sevoflurane anesthesia
Scientific Title
The effect of nitrous oxide on the ocular pressure under remifentanil and sevoflurane anesthesia
Scientific Title:Acronym
The effect of nitrous oxide on the ocular pressure under remifentanil and sevoflurane anesthesia
Region
| Japan |
Condition
Condition
patients scheduled for elective abdominal surgery
Classification by specialty
| Gastrointestinal surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of N2O on the IOP in patients undergoing abdominal surgery under sevoflurane and remifentanil anesthesia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
IOP is measured at 20 min after induction of anesthesia (T0), 1 hour after T0 (T1), 2 hours after T0 (T2), and 3 hours after T0 (T3).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The patients receive 33% oxygen and 67% N2O,
Interventions/Control_2
The patients receive air instead of oxygen and N2O.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients scheduled for elective abdominal surgery
Key exclusion criteria
Patients with allergies, unstable angina, congestive heart failure, glaucoma and other ophthalmic disease and past history of eye surgery
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Goyagi |
Organization
Akita University Graduate School of Medicine
Division name
Anesthesiology and Intensive Care Medicine
Zip code
Address
1-1-1, Hondo, Akita-city, Akita
TEL
018-884-6175
tgoyagi@doc.med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Goyagi |
Organization
Akita University Graduate School of Medicine
Division name
Anesthesiology and Intensive Care Medicine
Zip code
Address
1-1-1, Hondo, Akita-city, Akita
TEL
018-884-6175
Homepage URL
tgoyagi@doc.med.akita-u.ac.jp
Sponsor or person
Institute
Akita University Graduate School of Medicine, Department of Anesthesiology and Intensive Care Medicine
Institute
Department
Personal name
Funding Source
Organization
Akita University Graduate School of Medicine, Department of Anesthesiology and Intensive Care Medicine
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
| 2015 | Year | 12 | Month | 17 | 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
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
| 2013 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 17 | Day |
Last modified on
| 2015 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023372
