UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043496 |
|---|---|
| Receipt number | R000049606 |
| Scientific Title | Effects of earmuffs and eye masks on propofol sedation during spinal anesthesia |
| Date of disclosure of the study information | 2021/03/02 |
| Last modified on | 2022/09/01 09:12:21 |
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Basic information
Public title
Effects of earmuffs and eye masks on propofol sedation during spinal anesthesia
Acronym
Earmuffs and eye masks during sedation
Scientific Title
Effects of earmuffs and eye masks on propofol sedation during spinal anesthesia
Scientific Title:Acronym
Earmuffs and eye masks during sedation
Region
| Asia(except Japan) |
Condition
Condition
IV sedation during spinal anesthesia for lower limb orthopedic surgery
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the effects of earmuffs and eye masks on propofol sedation during spinal anesthesia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Propofol usage (mg/kg/hour)
Key secondary outcomes
Propofol target concentration, the time to achieve proper sedation confirmed with the BIS score under 80, spinal block level, satisfaction score about sedation during anesthesia, PCA/antiemetics usage during 24 postoperative hours
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
In the intervention group, the patients are applied with earmuffs and eye masks after proper spinal anesthesia is confirmed and IV sedation with propofol is started.
Interventions/Control_2
In the control group, the patients are not applied with earmuffs and eye masks during the sedation.
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
| 19 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
- ASA I and II
- Lower limb orthopedic surgeries
- Spinal anesthesia
- supine operational position
Key exclusion criteria
- General anesthesia
- Combined spinal-epidural anesthesia
- Patients who do not want sedation during operation
- H/O allergic reaction to propofol
- Lateral decubitus or prone position
- Day surgery
- Hearing impairment
- Substance abuse
- Cognitive or memory impairment
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Sang-Hwan |
| Middle name | |
| Last name | Do |
Organization
Seoul National University Bundang Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
13620
Address
82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 13620, Republic of Korea
TEL
82-31-787-7499
shdo@snu.ac.kr
Public contact
Name of contact person
| 1st name | Jin-Woo |
| Middle name | |
| Last name | Park |
Organization
Seoul National University Bundang Hospital
Division name
Department of Anesthesiology and Pain Medicine
Zip code
13620
Address
82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 13620, Republic of Korea
TEL
82-31-787-7509
Homepage URL
jinul8282@gmail.com
Sponsor or person
Institute
Seoul National University Bundang Hospital
Institute
Department
Personal name
Funding Source
Organization
Seoul National University Bundang Hospital
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Republic of Korea
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seoul National University Bundang Hospital
Address
82 Gumi-ro, 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 13620, Republic of Korea
Tel
82-31-787-8801
snubhirb@gmail.com
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
| 2021 | Year | 03 | Month | 02 | 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
80
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
Terminated
Date of protocol fixation
| 2021 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 02 | Day |
Last modified on
| 2022 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049606
