UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Effects of Intravenous Anesthetics on QT interval during Anesthetic Induction with Desflurane
Title of the study (Brief title)	The Effects of Intravenous Anesthetics on QT interval during Anesthetic Induction with Desflurane
Region	Japan

Condition
Condition	The patients who undergo lumbar surgery
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is the effects of intravenous anesthetics(propofol or thiamylal) on QT interval during anesthetic induction with Desflurane
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	QT interval time from pre-induction to after intubation
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) 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	Patients receive fentanyl 3ug/kg and after 2 min, 1.5mg/kg propofol . Rocuronium(0.6mg/kg) and Desflurane (3% inhaled concentration,increasing 1% every 4 ventilation for 6%) are administrated immediately after loss of consciousness. Tracheal intubation is perfomed 3 min after Rocuronium injection. Heart rate(HR),mean artrial pressure(MAP),bispectral index score(BIS),and the heart rate corrected QT(QTc) interval on 12-lead electrocardiogram are recorded immediately before fentanyl administration(T1),2min after fentanyl injection(T2),1 min after propofol injection(T3),3min after Desflurane administration(T4), and 2min after intubation(T5).
Interventions/Control_2	Patients receive fentanyl 3ug/kg and after 2 min, 5mg/kg thiamylal. Rocuronium(0.6mg/kg) and Desflurane (3% inhaled concentration,increasing 1% every 4 ventilation for 6%) are administrated immediately after loss of consciousness. Tracheal intubation is perfomed 3 min after Rocuronium injection. Heart rate(HR),mean artrial pressure(MAP),bispectral index score(BIS),and the heart rate corrected QT(QTc) interval on 12-lead electrocardiogram are recorded immediately before fentanyl administration(T1),2min after fentanyl injection(T2),1 min after thiamylal injection(T3),3min after Desflurane administration(T4), and 2min after intubation(T5).
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	The patients who undergo lumbar spine surgery with ASA risk 1 or 2
Key exclusion criteria	1.heart disease 2.arrhythmia 3.antiarrhythmia drug 4.antipsychotic drug 5.hypo/hyper kalemia(<3.5mEq/L, >5.5mEq/L) 6.asthma 7.BMI>30
Target sample size	50

Research contact person
Name of lead principal investigator	Yoshiaki Terao
Organization	Nagasaki Rosai Hospital
Division name	Department of anesthesia
Address	2-12-5,setogoe,sasebo,Nagasaki,Japan
TEL	0956-49-2191
Email	yoterao@na-robyo.jp

Public contact
Name of contact person	Shozo Tominaga
Organization	Nagasaki Rosai Hospital
Division name	Department of anesthesia
Address	2-12-5,setogoe,sasebo,Nagasaki,Japan
TEL	0956-49-2191
Homepage URL
Email	tommy1121elephant@gmail.com

Sponsor
Institute	Nagasaki Rosai Hospital Medical Office
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 08 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 27 Day
Anticipated trial start date	2016 Year 08 Month 22 Day
Last follow-up date	2017 Year 06 Month 30 Day
Date of closure to data entry	2017 Year 09 Month 18 Day
Date trial data considered complete	2017 Year 09 Month 18 Day
Date analysis concluded	2017 Year 10 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Fifty-three patients, 38male and 15female, were enrolled in the study. Of these, 3 patients (2 male, 1 from each group, and 1 female from Group T were excluded because their ECG data were wrongly entered in the software. Therefore, 50 patients were included in the final analysis.There were no significant differences between the 2 groups. There were no significant differences in ETdes between the 2 groups. BIS and MAP were significantly decreased after anesthesia induction in both groups. MAP in Propofol group was lower than Thiamylal group after anesthesia induction. There were no significant differences in HR and QTcD at any recorded time point. In Group P, the QTc interval values at T3 was significantly shortened compared with the QTc interval at T1. In Group T, the QTc interval values at T4 and T5 were significantly prolonged compared with the QTc interval at T1. The QTc intervals at T3, T4 and T5 in Group T were significantly longer than those in Group P.
Other related information

Management information
Registered date	2016 Year 08 Month 21 Day
Last modified on	2018 Year 03 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027300