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The comparison of Propofol and Isoflurane on arterial oxygenation pressure, mean arterial pressure and heart rate variations following one-lung ventilation in thoracic surgeries

Protocol summary

Summary
Objectives: Determination and comparison of effect of Propofol and Isoflurane on arterial oxygenation pressure, mean arterial pressure and heart rate variations following one-lung ventilationin thoracic surgeries Design: Randomized, not-blinded, Target sample size 61 people. The major inclusion criteria: The age range of 18-75 years old; ASA class I (Healthy person) and III (Severe systemic disease); The consent to undergo thoracic surgery with OLV, according to the study conditions The major exclusion criteria: Liver malfunction (Aspartate transaminase (AST) more than 40, Alanine transaminase (ALT) more than 40); Ischemic or valvular heart disease (history of cardiovascular diseases, physical status, Electrocardiogram (EKG) and echocardiography of the patients were analyzed); Recent use of anesthetic medications; Obstructive and end-stage restrictive pulmonary disease; Patients with one-lung ventilationin (OLV) less than 30 min; Patients with End -Tidal CO2 (ETCO2) more than 45 mmHg, and the respiratory rate of 12 breaths per minute; Patients who have pathological problems in the left lung (pulmonary), according to High Resolution Computed Tomography (HRCT) and pulmonary function tests (PFT) before the surgery. Intervention group: Intervention group: propofol (100 μg/kg/min), During Surgery. Control group: Control group: one Mac (1.1%) isoflurane, During surgery. Primary outcome measure: mean pressure of arterial oxygen and Mean Arterial pressure and Heart rate, During two lung ventilation and in 5, 10 and 20 minute after one lung ventilation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013122615942N1
Registration date: 2014-02-03, 1392/11/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-02-03, 1392/11/14
Registrant information
Name
Mohammad Reza Rhnama Zadeh
Name of organization / entity
Ghaem Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 1768 7898
Email address
rahnamazadehm891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Mashhad University of Medical Sciences
Expected recruitment start date
2012-02-01, 1390/11/12
Expected recruitment end date
2013-02-01, 1391/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of Propofol and Isoflurane on arterial oxygenation pressure, mean arterial pressure and heart rate variations following one-lung ventilation in thoracic surgeries
Public title
Propofol and Isoflurane effects in thoracic surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
The major inclusion criteria: The age range of 18-75 years old; ASA class I (Healthy person) and III (Severe systemic disease); The consent to undergo thoracic surgery with OLV, according to the study conditions The major exclusion criteria: Liver malfunction (Aspartate transaminase (AST) more than 40, Alanine transaminase (ALT) more than 40); Ischemic or valvular heart disease (history of cardiovascular diseases, physical status, Electrocardiogram (EKG) and echocardiography of the patients were analyzed); Recent use of anesthetic medications; Obstructive and end-stage restrictive pulmonary disease; Patients with one-lung ventilationin (OLV) less than 30 min; Patients with End -Tidal CO2 (ETCO2) more than 45 mmHg, and the respiratory rate of 12 breaths per minute; Patients who have pathological problems in the left lung (pulmonary), according to High Resolution Computed Tomography (HRCT) and pulmonary function tests (PFT) before the surgery.
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research of Mashhad University of Medical Sciences, Ghoreishi Building, Daneshgah street, Mashhad
City
Mashhad
Postal code
Approval date
2013-02-02, 1391/11/14
Ethics committee reference number
910182

Health conditions studied

1

Description of health condition studied
Anasthesia
ICD-10 code
Y48.4
ICD-10 code description
Anaesthetic, unspecified

Primary outcomes

1

Description
mean pressure of arterial oxygen
Timepoint
During two lung ventilation and in 5, 10 and 20 minute after one lung ventilation
Method of measurement
ABG Test by GEM premier 3000

2

Description
Mean Arterial pressure
Timepoint
During two lung ventilation and in 5, 10 and 20 minute after one lung ventilation
Method of measurement
ABG Test by GEM premier 3000

3

Description
Heart Rate
Timepoint
During two lung ventilation and in 5, 10 and 20 minute after one lung ventilation
Method of measurement
ABG Test by GEM premier 3000

Secondary outcomes

1

Description
Arterial oxygen saturation
Timepoint
During ventilation of two lungs, 5, 10 and 20 minute after one lung ventilation
Method of measurement
Monitoring

Intervention groups

1

Description
Intervention group: Propofol (100 μg/kg/min), During Surgery
Category
Prevention

2

Description
Control group: one Mac (1.1%) Isoflurane, During surgery
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Mohammad Reza Rahnamazadeh
Street address
Ghaem Hospital, Ahmadabad Street, Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Ramezani
Street address
Vice Chancellor for Research of Mashhad University of Medical Sciences, Ghoreishi Building, Daneshgah Street, Mashhad
City
Mashhad
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Mashhad University of Medical Sciences
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
Ghaem Hospital
Full name of responsible person
Mohammad Reza Rahnamazadeh
Position
Student
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmadabaad street, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1768 7898
Fax
Email
rahnamazadehm891@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ghaem Hospital
Full name of responsible person
Alireza Sharifian Atar
Position
Anesthesiologist
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmadabad Street, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1840 0978
Fax
Email
sharifiana@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ghaem Hospital
Full name of responsible person
Mohammad Reza Rahnamazadeh
Position
student
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmadabad Street, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1768 7898
Fax
Email
rahnamazadehm891@mums.ac.ir
Web page address

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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