UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009527 |
|---|---|
| Receipt number | R000011189 |
| Scientific Title | A clinical trial of warm versus cold tetracaine for topical corneal anesthesia in cataract surgery |
| Date of disclosure of the study information | 2012/12/11 |
| Last modified on | 2013/04/22 19:09:26 |
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Basic information
Public title
A clinical trial of warm versus cold tetracaine for topical corneal anesthesia in cataract surgery
Acronym
warm versus cold tetracaine for cataract surgery
Scientific Title
A clinical trial of warm versus cold tetracaine for topical corneal anesthesia in cataract surgery
Scientific Title:Acronym
warm versus cold tetracaine for cataract surgery
Region
| Asia(except Japan) |
Condition
Condition
Warming enhances the effect and duration of anesthesia of local anesthetics. No study has been done regarding the effects of warming local anesthetics for topical uses.
Classification by specialty
| Medicine in general | Surgery in general | Ophthalmology |
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
postoperative pain in warm and cold tetracain groups
Basic objectives2
Others
Basic objectives -Others
Burning sensation on instilation in warm and cold tetracaine groups
Patient and surgen sutisfaction in warm and cold tetracaine groups
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Means of visual analog score for postoperative pain in warm and cold tetracaine groups
Key secondary outcomes
Distribution of different degrees of patient and surgeon satisfaction (high, medium, low) in warm and cold tetracaine groups
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Warm tetracaine solution for topical anesthesia of cornea
Interventions/Control_2
Cold (room temprature) tetracaine solution for topical anesthesia of cornea
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cataract surgery, adult, topical anesthesia, co-operative informative patients
Key exclusion criteria
Patient refusal
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mahmoud Saghaei |
Organization
Isfahan University of Medical Sciences
Division name
Department of Anesthesia
Zip code
Address
Feiz Medical Center
TEL
+983116249031
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mahmoud Saghaei |
Organization
Isfahan University of Medical Sciences
Division name
Department of Anesthesia
Zip code
Address
Feiz Medical Center
TEL
+983116249031
Homepage URL
http://www.saghaei.net
mahmood.saghaei@gmail.com
Sponsor or person
Institute
Department of Anesthesia, Isfahan University of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Research Department, Faculty of Medicine, Isfahan University of Medical Sciences
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Iran
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
Isfahan University of Medical Sciences, Department of Anesthesia, Feiz Medical Center
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 11 | 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 | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | 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
Management information
Registered date
| 2012 | Year | 12 | Month | 11 | Day |
Last modified on
| 2013 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011189
