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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023707
Receipt No. R000027300
Scientific Title The Effects of Intravenous Anesthetics on QT interval during Anesthetic Induction with Desflurane
Date of disclosure of the study information 2016/08/22
Last modified on 2018/03/16

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Basic information
Public title The Effects of Intravenous Anesthetics on QT interval during Anesthetic Induction with Desflurane
Acronym The Effects of Intravenous Anesthetics on QT interval during Anesthetic Induction with Desflurane
Scientific Title The Effects of Intravenous Anesthetics on QT interval during Anesthetic Induction with Desflurane
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshiaki Terao
Organization Nagasaki Rosai Hospital
Division name Department of anesthesia
Zip code
Address 2-12-5,setogoe,sasebo,Nagasaki,Japan
TEL 0956-49-2191
Email yoterao@na-robyo.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shozo Tominaga
Organization Nagasaki Rosai Hospital
Division name Department of anesthesia
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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. 
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 06 Month 27 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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