UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of cough preventing effect of remifentanil between in sevoflurane and propofol anesthesia
Title of the study (Brief title)	Comparison of cough preventing effect of remifentanil between in sevoflurane and propofol anesthesia
Region	Japan

Condition
Condition	patients undergoing general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effect of remifentanil of preventing coughing in sevoflurane and propofol anesthesia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the half maximal effective dose(ED50) values of remifentanil for preventing coughing
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administer general anesthesia with propofol and investigate the half maximal effective dose (ED50) values of remifentanil for preventing coughing against tracheal suctioning by Dixon's up down method
Interventions/Control_2	Administer general anesthesia with sevoflurane and investigate the half maximal effective dose (ED50) values of remifentanil for preventing coughing against tracheal suctioning by Dixon's up down method
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	60 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	American Society of Anesthesiologists physical status 1-2 patients undergoing elective operations under general anesthesia
Key exclusion criteria	histories of respiratory diseases
Target sample size	80

Research contact person
Name of lead principal investigator	Ikeshita Kazutshi
Organization	Yao Tokushukai general hospital
Division name	department of anesthesia
Address	1-17 Wakakusa-cho Yao Osaka 581-0011
TEL	0729-93-8501
Email	ikeshita@eco.ocn.ne.jp

Public contact
Name of contact person	Ikeshita Kazutoshi
Organization	Yao Tokushukai general hospital
Division name	department of anesthesia
Address	1-17 Wakakusa-cho Yao Osaka 581-0011
TEL	0729-93-8501
Homepage URL
Email	ikeshita@eco.ocn.ne.jp

Sponsor
Institute	Yao Tokushukai general hospital
Institute
Department

Funding Source
Organization	Yao Tokushukai general hospital
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	八尾徳洲会総合病院（大阪府）

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 11 Day
Anticipated trial start date	2015 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 19 Day
Last modified on	2016 Year 08 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020734