UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of local anesthetics with adrenaline or felypressin on the QTc interval in elderly: a randomized double-blind crossover study.
Title of the study (Brief title)	The effect of local anesthetics with adrenalin or felypressin on the QTc interval in elderly
Region	Japan

Condition
Condition	Elderly aged over 65 years
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to enhance the safety use of the local anesthetics with adrenaline or felypressin in a dental care of elderly by means of investigating the effect of that on the QTc interval.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	QTc interval
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	Medicine
Interventions/Control_1	The intervention of this study is the administration of local anesthetics with adrenalin as an infiltration anesthesia
Interventions/Control_2	The intervention of this study is the administration of local anesthetics with felypressin as an infiltration anesthesia
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Elderly patients who visited Special care clinic-1 in Tokyo Medical and Dental University 2.Elderly patients undergoing two or more teeth extraction 3.Elderly patients with ASA physical status II-III 4.Elderly patients who are able to understand and subscribe to our informed consent
Key exclusion criteria	1. Elderly patient with a history of tachyarrhythmia 2. Elderly patient with severe renal or liver dysfunction. 3.Elderly patient with QT prolongation in the preoperative electrocardiogram
Target sample size	40

Research contact person
Name of lead principal investigator	Shunsuke Minakuchi
Organization	Tokyo Medical and Dental University
Division name	Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences
Address	1-5-45 Yushima,Bunkyo-ku,Tokyo
TEL	03-5803-5582
Email	s.minakuchi.gerd@tmd.ac.jp

Public contact
Name of contact person	Yuka Kyosaka
Organization	Tokyo Medical and Dental University
Division name	Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate Schoo
Address	1-5-45 Yushima,Bunkyo-ku,Tokyo
TEL	03-5803-5561
Homepage URL
Email	shika.qq@gmail.com

Sponsor
Institute	Tokyo Medical and Dental University
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)

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	2016 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 01 Day
Anticipated trial start date	2016 Year 09 Month 15 Day
Last follow-up date	2018 Year 01 Month 30 Day
Date of closure to data entry	2018 Year 02 Month 01 Day
Date trial data considered complete	2018 Year 04 Month 30 Day
Date analysis concluded	2018 Year 04 Month 30 Day

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

Management information
Registered date	2016 Year 07 Month 19 Day
Last modified on	2019 Year 01 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026564