Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000086763
Ethics application status
Approved
Date submitted
21/01/2013
Date registered
23/01/2013
Date last updated
23/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effective dose of remifentanil for control of hemodynamic response to insertion of the Streamlined Liner of the Pharyngeal Airway(SLIPA)
Scientific title
What is effective dose of remifentanil to control hemodynamic response to insertion of the Streamlined Liner of the Pharyngeal Airway(SLIPA)
Secondary ID [1] 281815 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemodynamic response to insertion of the Streamlined Liner of the Pharyngeal Airway(SLIPA)

 288164 0
Condition category
Condition code
Anaesthesiology 288528 288528 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Before insertion of SLIPA, remifentanil (0.5microg/kg, 1.0microg/kg, 1.5microg/kg, 2.0microg/kg ) is injected.
there are 4 different intervention groups who receive their allocated dose once only.
remifentanil is injected intravenously.
Intervention code [1] 286366 0
Treatment: Drugs
Intervention code [2] 286376 0
Prevention
Comparator / control treatment
Before insertion of SLIPA, normal saline is injected
Control group
Placebo

Outcomes
Primary outcome [1] 288685 0
Systolic Blood Pressure by noninvasive blood pressure cuff
Timepoint [1] 288685 0
postinsertion 1, 2, 3 min
Primary outcome [2] 288695 0
Mean Arterial Pressure by noninvasive blood pressure cuff
Timepoint [2] 288695 0
post insertion 1,2,3 min
Primary outcome [3] 288700 0
Diastolic Blood Pressure by noninvasive blood pressure cuff
Timepoint [3] 288700 0
Post intubation 1,2,3 min
Secondary outcome [1] 300763 0
Heart Rate by electrocardiogram
Timepoint [1] 300763 0
1, 2, 3 min postinsertion

Eligibility
Key inclusion criteria
Patients with healthy and aged 20-65 years old, who were planned general anesthesia.
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
cardiovascular or pulmonary disease, reflux esophagitis, obesity (BMI > 30 kg/m²), or were pregnant, or were addicted to opioids, sedatives, or other medications

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The details of the series are kept in a set of sealed envelopes, each bearing only the case number on the outside. After admitting into the operating room and just before the induction of anaesthesia, the numbered envelope was opened and the card inside determined which group the patient would be affiliated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization into one of the five groups was based on Excel random-number generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/01/2011
Actual
3/01/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 4816 0
Korea, Republic Of
State/province [1] 4816 0
seoul

Funding & Sponsors
Funding source category [1] 286600 0
University
Name [1] 286600 0
Chung-Ang University
Country [1] 286600 0
Korea, Republic Of
Primary sponsor type
Hospital
Name
Chung-Ang University
Address
Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Country
Korea, Republic Of
Secondary sponsor category [1] 285387 0
None
Name [1] 285387 0
Address [1] 285387 0
Country [1] 285387 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288673 0
Institutional Board of Chung-Ang University School of Medicine
Ethics committee address [1] 288673 0
Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Ethics committee country [1] 288673 0
Korea, Republic Of
Date submitted for ethics approval [1] 288673 0
Approval date [1] 288673 0
27/12/2010
Ethics approval number [1] 288673 0

Summary
Brief summary
A single administration of remifentanil can effectively suppress hemodynamic changes due to the insertion of Streamlined Liner of the Pharyngeal Airway. What is the Effective dose of remifentanil needed to suppress hemodynamic response from Streamlined Liner of the Pharyngeal Airway insertion?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37218 0
Prof Hyun Kang
Address 37218 0
Department of Anaesthesiology and Pain Medicine Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Country 37218 0
Korea, Republic Of
Phone 37218 0
+82-2-6299-2571, 2579, 2586
Fax 37218 0
Email 37218 0
[email protected]
Contact person for public queries
Name 37219 0
Prof Hyun Kang
Address 37219 0
Department of Anaesthesiology and Pain Medicine Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Country 37219 0
Korea, Republic Of
Phone 37219 0
+82-2-6299-2571, 2579, 2586
Fax 37219 0
+82-2-6299-2585
Email 37219 0
[email protected]
Contact person for scientific queries
Name 37220 0
Prof Hyun Kang
Address 37220 0
Department of Anaesthesiology and Pain Medicine Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Country 37220 0
Korea, Republic Of
Phone 37220 0
+82-2-6299-2571, 2579, 2586
Fax 37220 0
Email 37220 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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