UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023707 |
|---|---|
| Receipt number | 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 17:34:05 |
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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
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
tommy1121elephant@gmail.com
Sponsor or person
Institute
Nagasaki Rosai Hospital Medical Office
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027300
