Spinal fusion surgery is often associated with a high rate of bleeding. The aim of this study is examining the effect of patients ventilation with two different amount of tidal volume( low & usual volume) on the amount of blood loss during posterior spinal fusion (PSF) surgery. So in a randomized double blind clinical trial, 34 patients 18-60 years old with ASA class I and II, candidated for PSF, will be divided in two group. Anesthesia plan and drugs are the same in both group. In group (1) after prone positioning, patients will be ventilated with 6 ml/kg tidal volume but in group (2) 10 ml/kg TV will be used. other setting are the same between two group. The volume of blood loss during the operation (blood collected in suction reservoir and bloody sponges) calculated as the initial outcome. and surgeon satisfaction from the operative field will be assessed by a standard scoring system as the secondary outcome. Collected data will be analysed and compared between two group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013100111398N4
Registration date:2013-11-12, 1392/08/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-11-12, 1392/08/21
Registrant information
Name
Mohammad Reza Ghodraty
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6762
Email address
m-ghodrati@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences, vice Chancellor for research affairs
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Tidal Volume on operative blood loss in patients undergoing posterior spinal fusion in Firozgar hospital during 2012-2013
Public title
Evaluation of the effect of tidal Volume on operative blood loss
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who candidate for posterior spinal fusion under general anesthesia; Consent to participate in research project; ASA physical status I-II; Age between 18 years old to 60 years old; BMI< 30
Exclusion criteria: Disagreement for participation; ASA physical status more than II; Emergency surgery; History of previous spinal surgery; Respiratory diseases; Coagulopathies; Cardiovascular disease; Hypertension; Kidney or liver disease; Diabetes Mellitus; History of taking drugs such as: beta blockers; Calcium channel blockers; Digoxin; Anticoagulant; Clonidine; Alcohol and drug abuse; Tumor in the site of surgery
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
34
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
Research Deputy of Iran University of Medical Sciences, Ethics Committee
Street address
5th Floor, central building, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
-
Approval date
2012-06-25, 1391/04/05
Ethics committee reference number
1037- 05.04.91
Health conditions studied
1
Description of health condition studied
Thoracho-lumbar spine fracture
ICD-10 code
T02.1
ICD-10 code description
Fractures involving thorax with lower back and pelvis
Primary outcomes
1
Description
The volume of blood loss during surgery
Timepoint
End of surgery
Method of measurement
Volume of blood collected in the suction reservoir and bloody sponges.
Secondary outcomes
1
Description
Surgeon satisfaction from operative field
Timepoint
End of operation
Method of measurement
Standard scoring score
Intervention groups
1
Description
In intervention group after giving the prone position to the patients, ventilation with low tidal volume (6 ml/kg) will be used until the end of surgery.
Category
Other
2
Description
In control group traditional value of tidal volume ( 10 ml/kg) will be used for ventilation during operative period
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Mohammad Reza Ghodraty MD.
Street address
Department of Anesthesia, Firoozgar Hospital, Beh-Afarin St. Karim Khan Av.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy, Iran University of Medical Siences
Full name of responsible person
Dr Motavalian MD.
Street address
5th floor, central bulding, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy, Iran University of Medical Siences
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
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Ghodraty MD.
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesia Department, Firoozgar Hospital, Beh-Afarin St. Karim Khan Av.
City
Tehran
Postal code
Phone
+98 21 8894 6762
Fax
Email
m-ghodrati@tums.ac.irmrghodrati@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammadreza Ghodrati, Dr
Position
Assistant proffesor of Anesthesia
Other areas of specialty/work
Street address
Anesthesia Department, Firoozgar Hospital, Beh-Afarin St. Karim Khan Av.
City
Tehran
Postal code
Phone
+98 21 8894 6762
Fax
Email
m-ghodrati@tums.ac.ir mrghodrati@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Ghodraty MD.
Position
Assistant professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesia Department, Firoozgar Hospital, Beh-Afarin St. Karim Khan Av.
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)