UMIN-CTR Clinical Trial

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
Email	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
Email	anesth@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013600