UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of sevoflurane on the QT interval in patients with diabetes
Title of the study (Brief title)	The effects of sevoflurane on the QT interval in patients with diabetes
Region	Japan

Condition
Condition	diabetes
Classification by specialty	Cardiology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the effects on the ECG QT interval by sevoflurane in diabetes
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	ECG QTc interval Sevoflurane administration before and After administration, 5 minutes, 10 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes
Key secondary outcomes	ECG Tp-e interval Sevoflurane administration before and After administration, 5 minutes, 10 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	general anesthetic patient
Key exclusion criteria	Heart surgery Pregnant woman Atrial fibrillation Bundle branch block
Target sample size	74

Research contact person
Name of lead principal investigator	Seishi Kimura
Organization	Kindai University Faculty of Medicine
Division name	Department of Anesthesiology
Address	377-2 Ohno-higashi, Osaka-sayama 589-8511, Japan
TEL	072-366-0221
Email	s-kimura@med.kindai.ac.jp

Public contact
Name of contact person	Seishi Kimura
Organization	Kindai University Faculty of Medicine
Division name	Department of Anesthesiology
Address	377-2 Ohno-higashi, Osaka-sayama 589-8511, Japan
TEL	072-366-0221
Homepage URL
Email	s-kimura@med.kindai.ac.jp

Sponsor
Institute	Department of Anesthesiology, Kindai University Faculty of Medicine
Institute
Department

Funding Source
Organization	Department of Anesthesiology, Kindai University Faculty of Medicine
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	近畿大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 15 Day
Anticipated trial start date	2014 Year 09 Month 01 Day
Last follow-up date	2017 Year 12 Month 01 Day
Date of closure to data entry	2017 Year 12 Month 01 Day
Date trial data considered complete	2017 Year 12 Month 01 Day
Date analysis concluded	2017 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0188555
Results	In the hyperglycemic group, the QTc interval is extended, but the Tp - ec interval is not prolonged.
Other related information	We enrolled normoglycemic patients (HbA1c: <6.5%) (NG group) and chronically hyperglycemic patients (HbA1c: >=6.5%) (HG group). The QT interval and Tp-e interval (from the peak to the end of the T wave were measured before and at 5, 10, 30, 60, 90, and 120 min after sevoflurane administration, and corrected for the RR interval using Bazett's formula (QTc and Tp-ec) This research is a prospective study. Those subjects who underwent surgery at the institution starting January 2016 were eligible for selection criteria.

Management information
Registered date	2016 Year 01 Month 21 Day
Last modified on	2018 Year 02 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023863