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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003287
Receipt No. R000003978
Scientific Title Random comparison test for the better anesthetic method among three kinds of combination groups of sevoflurane and remifentanil at the time of tracheal intubation
Date of disclosure of the study information 2010/03/08
Last modified on 2012/03/08

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Basic information
Public title Random comparison test for the better anesthetic method among three kinds of combination groups of sevoflurane and remifentanil at the time of tracheal intubation
Acronym Assessment of proper combination of sevoflurane and remifentanil at the time of tracheal intubation
Scientific Title Random comparison test for the better anesthetic method among three kinds of combination groups of sevoflurane and remifentanil at the time of tracheal intubation
Scientific Title:Acronym Assessment of proper combination of sevoflurane and remifentanil at the time of tracheal intubation
Region
Japan

Condition
Condition About 50 patients who agreed this study's object among the patients scheduled operation under general anesthesia in this hospital
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Vascular surgery Chest surgery Obsterics and gynecology
Ophthalmology Dermatology Oto-rhino-laryngology
Orthopedics Urology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish proper anesthetic combination of sevoflurane and remifentanil from anesthetic induction to intubation using muscle relaxant rocuronium
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Assessment of anesthetic effect by blood pressure and heart rate and BIS value at the time of tracheal intubation
Key secondary outcomes Assessment of post operation for example of patient's satisfactory

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Groops who are given higher concentration's sevoflurane
Interventions/Control_2 Groops who are given higher concentration's remifentanil
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Patients who are scheduled operation under general anesthesia
Key exclusion criteria Patients who have severe complications
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroo Shimono
Organization Kagoshima University
Division name Department of Anesthesia and Resuscitation
Zip code
Address 8-35-1 Sakuragaoka Kagoshima City
TEL 099-275-5430
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroo Shimono
Organization Kagoshima University
Division name Department of Anesthesia and Resuscitation
Zip code
Address
TEL
Homepage URL
Email simo-396@m2.kufm.kagoshima-u.ac.jp

Sponsor
Institute kagoshima University
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 03 Month 08 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 Enrolling by invitation
Date of protocol fixation
2010 Year 03 Month 08 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 03 Month 04 Day
Last modified on
2012 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003978

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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