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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001564
Receipt No. R000001891
Scientific Title comparison of target-controlled infusion of remifentanil and sufentanil in blunting hemodynamic responses of orotracheal intubation
Date of disclosure of the study information 2008/12/12
Last modified on 2008/12/30

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Basic information
Public title comparison of target-controlled infusion of remifentanil and sufentanil in blunting hemodynamic responses of orotracheal intubation
Acronym comparison of target-controlled infusion of remifentanil and sufentanil in blunting hemodynamic responses of orotracheal intubation
Scientific Title comparison of target-controlled infusion of remifentanil and sufentanil in blunting hemodynamic responses of orotracheal intubation
Scientific Title:Acronym comparison of target-controlled infusion of remifentanil and sufentanil in blunting hemodynamic responses of orotracheal intubation
Region
Asia(except Japan)

Condition
Condition patients ASA class I-II who need anesthesia and orotracheal intubation to perform surgery
Classification by specialty
Anesthesiology Cardiovascular surgery Emergency medicine
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 comparison of remifentanil and sufentanil (administered with Target-controlled infusion technique) in preventing hemodynamic changes of tracheal intubation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes blood pressure and heart rate changes due to intubation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved 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 during induction of general anesthesia after hypnosis with target controlled infusion of propofol(BIS 45-60),target controlled infusion of remifentanil will be started with effect site target concentration of4 ng/ml,after 1 min of plasma-effect site equillibration laryngoscopy and tracheal intubation will be done.
Interventions/Control_2 during induction of general anesthesia after hypnosis with target controlled infusion of propofol(BIS 45-60),target controlled infusion of sufentanil will be started with effect site target concentration of0.2 ng/ml,after 1 min of plasma-effect site equillibration laryngoscopy and tracheal intubation will be done.
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
18 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria every patient who needs anesthesia and tracheal intubation to perform surgery
Key exclusion criteria systemic disease(cardiac,hepatic,diabetes,asthma),dependency to opioids or sedatives,trated or untreated hypertension
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Dr. naser yeganeh
Organization kermanshah university of medical sciences
Division name anesthesiology and intensive care department
Zip code
Address KUMS,kermanshah, Iran
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization kermanshah university of medical sciences
Division name anesthesiology and intensive care department
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Deputy of research and technology,kermanshah university of medical sciences
Institute
Department

Funding Source
Organization kermanshah university of medical sciences
Organization
Division
Category of Funding Organization Outside Japan
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
2008 Year 12 Month 12 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
Date of protocol fixation
2008 Year 08 Month 06 Day
Date of IRB
Anticipated trial start date
2008 Year 12 Month 01 Day
Last follow-up date
2009 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 12 Month 11 Day
Last modified on
2008 Year 12 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001891

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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