UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004648 |
|---|---|
| Receipt number | R000005520 |
| Scientific Title | The prophylactic effect of continuously infused landiolol started just before the end of surgery against tachycardia during tracheal extubation |
| Date of disclosure of the study information | 2010/12/01 |
| Last modified on | 2013/03/19 16:09:49 |
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Basic information
Public title
The prophylactic effect of continuously infused landiolol started just before the end of surgery against tachycardia during tracheal extubation
Acronym
The prophylactic effect of landiolol against tachycardia during tracheal extubation
Scientific Title
The prophylactic effect of continuously infused landiolol started just before the end of surgery against tachycardia during tracheal extubation
Scientific Title:Acronym
The prophylactic effect of landiolol against tachycardia during tracheal extubation
Region
| Japan |
Condition
Condition
Patients undergoing a surgery with general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is investigating the prophylactic effects of continuously infused landiolol started just before the end of surgery against tachycardia during tracheal extubation
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
the maximum heart rate during tracheal extubation
Key secondary outcomes
age, height, body weight, sex, preoperative complications
blood pressure and heart rate (at starting infusion of landiolol, 10 min after starting infusion of landiolol, maximum heart rate during tracheal extubation, after tracheal extubation, at discharging the patient from operating room)
operative time, anesthetic time, total fluid infusion, total operative bleeding, total volume of urine, total transfusion
total dose of fentanyl, total dose of remifentanil, total dose of landiolol
the incidence of side effect (bradycardia etc.)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
20 gamma group: Continuous infusion of landiolol (20 micro g/kg/min)is started about 10 min before the end of surgery and finished just after tracheal extubation.
Interventions/Control_2
10 gamma group: Continuous infusion of landiolol (10micro g/kg/min)is started about 10 min before the end of surgery and finished just after tracheal extubation.
Interventions/Control_3
control group: Continuous infusion of nomal saline is started about 10 min before the end of surgery and finished just after tracheal extubation.
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
Patients undergoing surgery under general anesthesia with tracheal intubation
Key exclusion criteria
patients with chronic heart failure, atrio-ventricular block, sick-sinus syndrome, diabetic ketoacidosis, hypothyroidism, WPW syndrome, hypotention (systric and diastric blood pressure should be more than 90 and 60, respectively), bradycardia (HR < 50), recieved nicardipine treatment for hypertention with extubation, asthma, with beta-blocker treatment, with anaphylaxis for flurbiprofen, with pregnancy, with anaphylaxis for landiolol, judged as unsuitable for this study
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshinori Horiuchi |
Organization
Bellland General Hospital
Division name
Department of Anesthesia
Zip code
Address
500-3 Higashiyama, Naka-ku, Sakai, Osaka, 599-8247, Japan
TEL
0722342001
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshinori Horiuchi |
Organization
Bellland General Hospital
Division name
Department of Anesthesia
Zip code
Address
500-3 Higashiyama, Naka-ku, Sakai, Osaka, 599-8247, Japan
TEL
0722342001
Homepage URL
t_horiuchi@seichokai.or.jp
Sponsor or person
Institute
Bellland General Hospital
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
| 2010 | Year | 12 | Month | 01 | 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
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
Terminated
Date of protocol fixation
| 2010 | Year | 08 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 01 | Day |
Last modified on
| 2013 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005520
| Research Plan | |
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| Registered date | File name |
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