UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049081 |
|---|---|
| Receipt number | R000055903 |
| Scientific Title | A validation study of sedation in cataract surgery using low-concentration nitrous oxide anesthesia A crossover design |
| Date of disclosure of the study information | 2022/09/30 |
| Last modified on | 2022/09/30 16:35:12 |
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Basic information
Public title
A validation study of sedation in cataract surgery using low-concentration nitrous oxide anesthesia A crossover design
Acronym
A study on the sedative effect in cataract surgery using low-concentration nitrous oxide anesthesia
Scientific Title
A validation study of sedation in cataract surgery using low-concentration nitrous oxide anesthesia A crossover design
Scientific Title:Acronym
A study on the sedative effect in cataract surgery using low-concentration nitrous oxide anesthesia
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the Sedative Effects of Low-Concentration nitrous oxide anesthesia in Cataract Surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bispectral Index
Key secondary outcomes
Heart rate, oxygen saturation, upper extremity systolic and diastolic blood pressure, subjective questionnaire
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Type of inhaled gas during surgery for both eyes cataract surgery Low-concentration nitrous oxide anesthesia in the first eye, oxygen only in the second eye
Interventions/Control_2
Type of inhaled gas during surgery for both eyes cataract surgery Oxygen only in the first eye, low-concentration nitrous oxide anesthesia in the second eye
Interventions/Control_3
Type of inhaled gas at surgery for both eyes cataract surgery Oxygen only for 1st eye, Oxygen only for 2nd eye
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
| 67 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cataract patients who underwent consecutive binocular cataract surgeries
Key exclusion criteria
Patients with known neurological disorders such as epilepsy, patients taking antipsychotic drugs, patients with previous stroke, patients with implanted cardiac pacemakers, and patients with nasal obstruction disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Morii |
Organization
Medical corporation Asagiri Hospital
Division name
opthalmology
Zip code
673-0852
Address
1120-2 Asagiridai, Akashi-shi, Hyogo, Japan
TEL
078-912-7575
k-morii@asagiri-hp.or.jp
Public contact
Name of contact person
| 1st name | Koutarou |
| Middle name | |
| Last name | Ishigami |
Organization
Medical corporation Asagiri Hospital
Division name
Clinical Engineering Technician Office
Zip code
673-0852
Address
1120-2 Asagiridai, Akashi-shi, Hyogo, Japan
TEL
078-912-7575
Homepage URL
koutarou19931010@yahoo.co.jp
Sponsor or person
Institute
Medical corporation Asagiri Hospital
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Medical corporation Asagiri Hospital
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
Medical Corporation Yoshinokukai Asagiri Hospital Ethics Review Committee
Address
1120-2 Asagiridai, Akashi-shi, Hyogo, Japan
Tel
0778-912-7575
asagiri@asagiri-hp.or.jp
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
| 2022 | Year | 09 | Month | 30 | 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
30
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
| 2020 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 30 | Day |
Last modified on
| 2022 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055903
| 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 |
