TIn current study, we aimed to evaluate effect of dexmedetomidine drug use on arterial blood oxygenation level in patients undergo thoracic surgery. Adult patients with grade I or III of American Society of Anesthesiology (ASA), candidate for thoracotomy will be enrolled study and patients with severe cardiac, hepatic or renal diseases will be excluded. After, consecutive sampling, using randomly permuted blocks method, patients will be assigned to study groups. 42 patients will be randomly divided to two study groups, whereas, 21 patients will be assigned to study group (intravenous administration of anesthesia including dexmedetomidine infusion) and 21 patients will be assigned to control group (intravenous administration of anesthesia including normal saline serum infusion). Patients and physician recording variables will be blinded to patients' study groups allocation.
Arterial blood sampling will be done before differential lung ventilation (DLV), 10 minutes after DLV and 20 minutes before end of the DLV, in order to arterial blood oxygen saturation level measurement. In addition, dosage of other anesthetics used in both groups of the study will be recorded during operation. Two groups patients will be compared in terms of mentioned variables.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201610174731N15
Registration date:2017-01-20, 1395/11/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-20, 1395/11/01
Registrant information
Name
Hamze Hosseinzade
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 7055
Email address
hosseinz@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of research and development of Tabriz University of Medical Sciences.
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Dexmethomedin on oxygenation in patients with one lung ventilation during thracic srugery
Public title
The effect of Dexmethomedin on oxygenation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Class I or III according to ASA classification; aged between 18 to 65 year-old; candidate for elective thoracotomy with DLV. Exclusion criteria: severe cardiac disease; severe hepatic disease; severe renal disease; body mass index greater than 30; anemia (hemoglobin less than 12mg / dl ); chest trauma; sensitivity to dexmetedomidin
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomly permuted blocks method used for patients randomized assignment to study groups
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Tabriz university of medical sceinces, Daneshgah square
City
Tabriz
Postal code
Approval date
2016-07-17, 1395/04/27
Ethics committee reference number
IR.TBZMED.REC.1395.506
Health conditions studied
1
Description of health condition studied
Drug effect on lung ventilation
ICD-10 code
J95
ICD-10 code description
Intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified
Primary outcomes
1
Description
evaluating dexmetedomidine effects on arterial oxygenation
Timepoint
10 minutes after anesthesia and 20 minutes before end of the operation
Method of measurement
arterial blood oxygen saturation measurement
Secondary outcomes
1
Description
measurement the use of other anesthetic agents during dexmetedomidine administration
Timepoint
during operation
Method of measurement
measuring dosage of anesthetic agents administered other than dexmetedomidine
Intervention groups
1
Description
control group: 1 microgram per kilogram body weight, dexmetedomidine will be given during first 10 minutes after anesthesia and infusion will be administered in dosage of 0.9 microgram per kilogram body weight during per hour.
Category
Treatment - Drugs
2
Description
control group: 1 microgram per kilogram body weight, placebo (normal saline serum) will be given during first 10 minutes after anesthesia and infusion will be administered in dosage of 0.9 microgram per kilogram body weight during per hour.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Imam Reza (AS) Tabriz
Full name of responsible person
Street address
Golgasht Street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz Medical University
Full name of responsible person
Alireza Ostadrahimi
Street address
Vice chancellor for research, Tabriz University of medical sceinces, Daneshgah square
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz Medical University
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
Dr. Hamzeh Hosseinzadeh
Position
Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 3334 1994
Fax
Email
hosseinz@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hamzeh Hosseinzadeh
Position
Professor
Other areas of specialty/work
Street address
Imam Reza hospital, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 3334 1994
Fax
Email
hosseinz@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hamzeh Hosseinzadeh
Position
Associate Professor, Specialist in Anesthesiology
Other areas of specialty/work
Street address
Imam Reza hospital, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 3334 1994
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)