UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015718 |
|---|---|
| Receipt number | R000018253 |
| Scientific Title | A clinical study investigating a relationship between the change in pupil size during an administration of remifentanil and hemodynamic change after an induction. |
| Date of disclosure of the study information | 2014/11/18 |
| Last modified on | 2015/05/18 17:13:52 |
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Basic information
Public title
A clinical study investigating a relationship between the change in pupil size during an administration of remifentanil and hemodynamic change after an induction.
Acronym
A clinical study investigating a relationship between the change in pupil size during an administration of remifentanil and hemodynamic change after an induction.
Scientific Title
A clinical study investigating a relationship between the change in pupil size during an administration of remifentanil and hemodynamic change after an induction.
Scientific Title:Acronym
A clinical study investigating a relationship between the change in pupil size during an administration of remifentanil and hemodynamic change after an induction.
Region
| Japan |
Condition
Condition
Patients who will have elective surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate a relationship between the change in pupil size during an administration of remifentanil and hemodynamic change after an induction.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between pupil size and hemodynamic parameters after an induction
Key secondary outcomes
Number of patients needed Atropine or Ephedrine
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administrations of remifentanil and propofol
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who will have elective surgery
Patients are ASA 1 or 2
Key exclusion criteria
Insufficient measurement
Patients who has eye disease
Patients who refuse to participate this study
Patients who take be-ta blocker
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Kakinohana |
Organization
University of the Ryukyus
Division name
Department of Anesthesiology, Faculty of Medicine
Zip code
Address
Uehara 207 banchi, Nishihara-cho Nakagami-gun, Okinawa
TEL
0988952221
anesthks@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Tadokoro |
Organization
University of the Ryukyus Hospital
Division name
Department of Anesthesiology
Zip code
Address
Uehara 207 banchi, Nishihara-cho Nakagami-gun, Okinawa
TEL
0988953331
Homepage URL
rover2727@yahoo.co.jp
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2014 | Year | 11 | Month | 18 | 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
| 2014 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The title at Ethical appraisal, "Research on the effect of opiate by light reflex ", is different from the title registered.
Management information
Registered date
| 2014 | Year | 11 | Month | 18 | Day |
Last modified on
| 2015 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018253
