UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Optimal sevoflurane concentration for tracheal intubation with rocuronium in infants: evaluation by heart rate variability
Title of the study (Brief title)	Optimal sevoflurane concentration for tracheal intubation with rocuronium in infants
Region	Japan

Condition
Condition	cleft lip
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the optimal sevoflurane concentration that would minimize changes in the hemodynamics and autonomic nervous activity during intubation using heart rate variability in infants.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	heart rate, blood pressure, heart rate variability
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	sevoflurane 3%
Interventions/Control_2	sevoflurane 4%
Interventions/Control_3	sevoflurane 5%
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	6 months-old >=
Gender	Male and Female
Key inclusion criteria	cleft lip patients aged under 6 months old with an American Society of Anesthesiologists physical status of 1 or 2 who were undergoing general anesthesia for elective cheiloplasty.
Key exclusion criteria	A history of epilepsy or significant cardiopulmonary, renal, or hepatic dysfunction, symptoms of an upper respiratory tract infection, or predictive signs of difficult intubation
Target sample size	68

Research contact person
Name of lead principal investigator	Hiroshi Hanamoto
Organization	Osaka University Graduate School of Dentistry
Division name	Department of Dental Anesthsiology
Address	1-8, Yamadaoka, Suita, Osaka, Japan
TEL
Email

Public contact
Name of contact person
Organization	Osaka University Graduate School of Dentistry
Division name	Department of Dental Anesthsiology
Address	1-8, Yamadaoka, Suita, Osaka, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Osaka University Graduate School of Dentistry
Institute
Department

Funding Source
Organization	Osaka University Graduate School of Dentistry
Organization
Division
Category of Funding Organization	Self funding
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	大阪大学歯学部附属病院

Other administrative information
Date of disclosure of the study information	2013 Year 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 11 Month 25 Day
Anticipated trial start date	2011 Year 05 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	2013 Year 02 Month 01 Day
Last modified on	2018 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011637