UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011627 |
|---|---|
| Receipt number | R000013600 |
| Scientific Title | The efficacy of deep breathing in preventing pain on propofol injection |
| Date of disclosure of the study information | 2013/09/02 |
| Last modified on | 2021/03/03 12:16:49 |
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Basic information
Public title
The efficacy of deep breathing in preventing pain on propofol injection
Acronym
The efficacy of deep breathing in preventing pain on propofol injection
Scientific Title
The efficacy of deep breathing in preventing pain on propofol injection
Scientific Title:Acronym
The efficacy of deep breathing in preventing pain on propofol injection
Region
| Japan |
Condition
Condition
Patients undergoing operations under general anesthesia, not limited to specific diseases
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether deep breathing attenuates pain induced by the injection of propofol
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Propofol injection pain
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
During anesthetic induction with continous infusion of propofol, subjects are ordered to breathe deeply, and we ask and record the extent of propofol-injection pain.
Interventions/Control_2
During anesthetic induction with continous infusion of propofol, we ask and record the extent of propofol-injection pain.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who undergo operations under general anesthesia
Key exclusion criteria
Patients who have respiratory comorbidities
Patients who have epilepsy
Patients who are graded as American Society of Anesthesiologists physical status 3, 4, or 5
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuaki Tanaka |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL
81-6-6645-2186
anesth@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuaki Tanaka |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL
81-6-6645-2186
Homepage URL
anesth@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
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
| 2013 | Year | 09 | 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
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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 02 | Day |
Last modified on
| 2021 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013600
