UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on effectiveness of local anesthetic injected by the pre-administration method in tooth extracted patients with essential hypertension
Title of the study (Brief title)	A study on local anesthetic injected by the pre-administration method for patients with essential hypertension
Region	Japan

Condition
Condition	Periodontitis Essential hypertension
Classification by specialty	Cardiology Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate the effect of divided administration of local anesthesia on the circulatory dynamics of essential hypertension patients at tooth extraction and examine its effectiveness.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	systolic blood pressure 1, 2, 3, 4, 5, 10 minutes after local anesthetic administration
Key secondary outcomes	diastolic blood pressure pulse rate rate pressure product

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	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	1 group: 2% lidocaine with 1/80,000 adrenaline 2.3 ml administration
Interventions/Control_2	2 group: 2% lidocaine with 1/80,000 adrenaline 0.5 ml pre-administration, 1.8 ml administration after 5 minutes
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Extraction is planned and adult patients with essential hypertension being treated
Key exclusion criteria	Patient taking medication contraindicated with adrenaline
Target sample size	60

Research contact person
Name of lead principal investigator	Tohru Akashiba
Organization	The Nippon Dental University Niigata Hospital
Division name	Oral and Maxillofacial Surgery
Address	1-8 Hamaura-cho, Chuo-ku Niigata , 951-8151, Japan
TEL	025-267-1500
Email	aka@ngt.ndu.ac.jp

Public contact
Name of contact person	Tohru Akashiba
Organization	The Nippon Dental University Niigata Hospital
Division name	Oral and Maxillofacial Surgery
Address	1-8 Hamaura-cho, Chuo-ku Niigata , 951-8151, Japan
TEL	025-267-1500
Homepage URL
Email	aka@ngt.ndu.ac.jp

Sponsor
Institute	The Nippon Dental University Niigata Hospital
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	2017 Year 07 Month 20 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 07 Month 20 Day
Anticipated trial start date	2017 Year 07 Month 24 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 07 Month 20 Day
Last modified on	2017 Year 07 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032290