UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001564 |
|---|---|
| Receipt number | 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 01:15:57 |
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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
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
Sponsor or person
Institute
Deputy of research and technology,kermanshah university of medical sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001891
