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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004648
Receipt No. 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

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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
Email

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
Email t_horiuchi@seichokai.or.jp

Sponsor
Institute Bellland General Hospital
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005520

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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