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Comparison of hemodynamic parameters between low flow Isoflurane and low flow Sevoflurane in patients during anesthesia with controlled ventilation Laryngeal Mask Airway

Protocol summary

Summary
Laryngeal mask airway is a simple device for airway protection and anesthesia with low complications, which is widely used in elective surgeries. In low flow anesthesia, an inhaled anesthetic gas with a breathing system in which the rate of re-breathing is at least 50% is used. Several studies compared the hemodynamic stability during isoflurane anesthesia with Sevoflurane which have shown different results. Therefore, this study aims to compare the hemodynamic stability between low flow Isoflurane and low flow Sevoflurane anesthesia during controlled ventilation with Laryngeal Mask Airway. Eighty adult patients with ASA I and II class, aging 20-75 years without the risk of airway problems, history of malignant hyperthermia, diabetes mellitus and kidney problems, candidates for elective surgery will be included in this study. Patients will be randomly divided into two groups, one group of low flow anesthesia with isoflurane and other group of low flow anesthesia with Sevo.f. Standard monitoring during induction of anesthesia in all patients will be done. Systolic blood pressure, diastolic blood pressure, heart rate, ETCO2 and mean arterial pressure will be measured every 5 minutes in each group. Therefore, this study aims to compare the hemodynamic stability between low flow Isoflurane and low flow Sevoflurane anesthesia during controlled ventilation with Laryngeal Mask Airway. Eighty adult patients with ASA I and II class, aging 20-60 years without the risk of airway problems, history of malignant hyperthermia, diabetes mellitus and kidney problems, candidates for elective surgery will be included in this study. Patients will be randomly divided into two groups, one group of low flow anesthesia with isoflurane and other group of low flow anesthesia with Sevo.f. Standard monitoring during induction of anesthesia in all patients will be done. Systolic blood pressure, diastolic blood pressure, heart rate, ETCO2 and mean arterial pressure will be measured every 5 minutes in each group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201202202582N4
Registration date: 2012-03-17, 1390/12/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-03-17, 1390/12/27
Registrant information
Name
Ata Mahmoodpoor
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 116 0888
Email address
mahmoodpoora@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-02-04, 1390/11/15
Expected recruitment end date
2012-07-05, 1391/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of hemodynamic parameters between low flow Isoflurane and low flow Sevoflurane in patients during anesthesia with controlled ventilation Laryngeal Mask Airway
Public title
Comparison of low flow Isoflurane and low flow Sevoflurane anesthesia during controlled ventilation with Laryngeal Mask Airway
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: Adult patients with ASA I and II class; aging 20-60 years; candidates for elective surgery Exclusion criteria: the possibility of airway problem; history of malignant hyperthermia; lack of proper monitoring; co2 absorbant failure; uncompensated diabetes mellitus; prolonged starvation; chronic and acute alcoholism; smoking; presence of severe kidney problems
Age
From 20 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Golgasht street
City
Tabriz
Postal code
Approval date
2011-02-28, 1389/12/09
Ethics committee reference number
4993/4/5

Health conditions studied

1

Description of health condition studied
Hemodynamic changes
ICD-10 code
R03
ICD-10 code description
Abnormal blood-pressure reading, without diagnosis

Primary outcomes

1

Description
Mean Arterial Pressure
Timepoint
every 5 minutes
Method of measurement
in mmHg using manometer

2

Description
heart rate
Timepoint
every 5 minutes
Method of measurement
beat in minute

Secondary outcomes

1

Description
side effects
Timepoint
every 5 minutes
Method of measurement
physical examination

Intervention groups

1

Description
in intervention group: sevoflurane 2-2.5% in initial phase and 3-3.5% in low flow phase
Category
Treatment - Drugs

2

Description
in control group: isoflurane with fresh gas flow of 6 L/min in initial phase and 1 L/min in low flow phase
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Nikookary hospital
Full name of responsible person
Ata Mahmoodpoor
Street address
Abbasi street
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences, Research chancellor
Full name of responsible person
Alireza Ostadrahimi
Street address
Golgasht street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences, Research chancellor
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hnieh Molseghi
Position
medical student
Other areas of specialty/work
Street address
Nikookary hospital, Abbasi street
City
Tabriz
Postal code
Phone
+98 41 1657 7340
Fax
Email
h.molseghi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmoodpoor
Position
Assistant Professor
Other areas of specialty/work
Street address
Nikookary hospital, Abbasi street
City
Tabriz
Postal code
Phone
+98 41 1657 7340
Fax
Email
amahmoodpoor@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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