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Trial registered on ANZCTR


Registration number
ACTRN12611000050954
Ethics application status
Approved
Date submitted
10/01/2011
Date registered
14/01/2011
Date last updated
14/01/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of hemodynamic parameters of isoflurane and sevoflurane during lowflow controlled anesthesia
Scientific title
Comparison of hemodynamic parameters between low flow Isoflurane and low flow Sevoflurane anesthesia during controlled ventilation with Laryngeal Mask Airway
Secondary ID [1] 253378 0
There is no secondary ID
Universal Trial Number (UTN)
U1111-1118-9670
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemodynamic Parameters during anesthesia(systolic and diastolic blood pressure and Heart rate) 260930 0
Condition category
Condition code
Anaesthesiology 259062 259062 0 0
Anaesthetics
Cardiovascular 259082 259082 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
maintenance of low flow Anestheia with volume controlled ventilation through Laryngeal Mask Airway(LMA)with sevoflurane(Inhaled anesthetic) with 2-2.5% in initial phase(10 minutes) and after that maintained on 3-3.5% till we reach near the time of ending operation., at first we set fresh gas flow at 6 lit/min and after that the fresh gas flow decreases to 1lit/min during 10-15 minutes. hemodynamic parameters will be monitored.
Intervention code [1] 257824 0
Treatment: Drugs
Comparator / control treatment
maintenance of low flow Anestheia with volume controlled ventilation through Laryngeal Mask Airway(LMA)with isoflurane(inhaled anesthesia) with 1.5-2% isoflurane for 10 minutes and after that 1-1.5% till we reach near the time of ending operation.at first we set fresh gas flow at 6 lit/min and after that the fresh gas flow decreases to 1lit/min during 10-15 minutes.hemodynamic parameters will be monitored.
Control group
Active

Outcomes
Primary outcome [1] 259919 0
hemodynamic parameters which will be assessed by monitoring systolic blood pressure,diastolic blood pressure by automatic sphygmomanometer and heart rate by electrocardiogram
Timepoint [1] 259919 0
During Maintenance of anesthesia at a regular time.(each 5 minutes)
Secondary outcome [1] 268814 0
Safety wich will be assessed with stable hemodynamic status
Timepoint [1] 268814 0
Maintenance of anesthesia

Eligibility
Key inclusion criteria
Adult patients(20-60) y.o with ASA physical status 1-2 who are candidated for elective surgery
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
difficult airway, history of malignant hyperthermia,alcoholism,uncomponsated diabetes mellitus, long duration of fasting,heavy smoking, renal failure and impared co2 absorbant.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 3134 0
Iran, Islamic Republic Of
State/province [1] 3134 0
East Azerbaijan

Funding & Sponsors
Funding source category [1] 258297 0
University
Name [1] 258297 0
Tabriz University of Medical Sciences
Country [1] 258297 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Tabriz University of Medical Sciences
Address
Golshahr street,Tabriz
5157663114
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 257460 0
None
Name [1] 257460 0
Address [1] 257460 0
Country [1] 257460 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260282 0
Ethics committee of tabriz University of Medical Sciences
Ethics committee address [1] 260282 0
Tabriz University,Daneshgah Ave, Tabriz
5157663114
Ethics committee country [1] 260282 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 260282 0
12/11/2010
Approval date [1] 260282 0
Ethics approval number [1] 260282 0

Summary
Brief summary
Laryngeal Mask Airway(LMA) is a good device for airway management which is used routinly in operating room nowadays.Low flow anesthesia is almost a new concept in maintenance of anesthesia which leads to better control of airway temperature and humidity with stable hemodynamic.
Previous studies showed that we can use isoflurane with controlled low flow anesthesia during operation. Sevoflurane is a new anesthetic which has some priorities to other anesthetics. But there are some concerns about its use during contooled low flow anesthesia with LMA. 80 patients will be enrolled in this study. Patients will be randomized to two 40 patient groups. In one group anesthesia will be maintained with isoflurane and in the other group will be maintained by sevoflurane. All patients will be ventilated through LMA with low flow anesthesia. Hemodynamic Parameters will be noted during anestheia for each person.
Trial website
There is not web site for study
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32074 0
Address 32074 0
Country 32074 0
Phone 32074 0
Fax 32074 0
Email 32074 0
Contact person for public queries
Name 15321 0
Ata Mahmoodpoor
Address 15321 0
General ICU,Shohada hospital, El-goli street, Tabriz
5157663114
Country 15321 0
Iran, Islamic Republic Of
Phone 15321 0
00984113851117
Fax 15321 0
00984113853171
Email 15321 0
[email protected]
Contact person for scientific queries
Name 6249 0
Ata Mahmoodpoor
Address 6249 0
General ICU,Shohada hospital, El-goli street, Tabriz
5157663114
Country 6249 0
Iran, Islamic Republic Of
Phone 6249 0
00984113851117
Fax 6249 0
Email 6249 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

Documents added manually
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Documents added automatically
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