The effect of Different Warmer’s Temperature on Core Temperature and Bleeding Rate in Patients Undergoing Posterior Spinal Fusion Surgery in Tehran Pars Hospital: Randomization Clinical Trial
The aim of this study is the comparison of the effect of two different warmer temperature levels on central temperature and bleeding rate in patients undergoing posterior spinal fusion surgery.
Design
In this study, patients will be undergoing entirely intravenous anesthesia in posterior spinal fusion surgery in Tehran Pars Hospital that will randomly be divided into two groups. The eligible patients will randomly be entered to one of the groups after signature of the consent. Sample size in this study is 90 patients.
Settings and conduct
This study will be performed on patients who have referred to Tehran Pars Hospital. The eligible patients will be undergoing entirely intravenous anesthesia in posterior spinal fusion surgery in Tehran Pars Hospital after signature of the consent. The patients will be divided randomly into two groups: A group: 38o C and B group: 40o C. In addition, all patients will be blinded about randomization and intervention of the study.
Participants/Inclusion and exclusion criteria
The inclusion criteria contain patients with risk of posterior spinal fusion surgery. In addition, the exclusion criteria include patients with ischemic heart disease; diabetes; kidney disease; hypertension; aging; infection; sepsis and coagulation disorders.
Intervention groups
Intervention group: The desired temperature in this group is 40° C.
Comparison group: The desired temperature in this group is 38° C.
Main outcome variables
The primary outcome variables are serum level of hemoglobin, hematocrit and platelet counts, mean core temperature, mean arterial blood pressure, heart rate, and respiratory rate that will be recorded before, during and after surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141225020434N2
Registration date:2017-12-20, 1396/09/29
Registration timing:retrospective
Last update:2017-12-20, 1396/09/29
Update count:0
Registration date
2017-12-20, 1396/09/29
Registrant information
Name
gita fotoohi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9059
Email address
hassani.v@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Different Warmer’s Temperature on Core Temperature and Bleeding Rate in Patients Undergoing Posterior Spinal Fusion Surgery in Tehran Pars Hospital: Randomization Clinical Trial
Public title
The effect of Different Warmer’s Temperature on Core Temperature and Bleeding Rate in Patients Undergoing Posterior Spinal Fusion Surgery in Tehran Pars Hospital
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidates for posterior spinal fusion surgery
In this study, randomization will be conducted on individuals. Table of random numbers will be used for randomization .
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, patients will be blind to the intervention groups and randomization process.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Science
Street address
Iran. Tehran. Hemat Highway. Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2015-05-04, 1394/02/14
Ethics committee reference number
IR.IUMS.REC.1395.1218
Health conditions studied
1
Description of health condition studied
Patients undergoing posterior spinal fusion surgery
ICD-10 code
G32.8
ICD-10 code description
Other specified degenerative disorders of nervous system in diseases classified elsewhere
Primary outcomes
1
Description
Core temperature
Timepoint
Before, during and after surgery
Method of measurement
Thermometer
2
Description
Heart rate
Timepoint
Before, during and after surgery
Method of measurement
Monitor Vital Signs
3
Description
Respiratory rate
Timepoint
Before, during and after surgery
Method of measurement
Monitor Vital Signs
4
Description
Arterial blood pressure
Timepoint
Before, during and after surgery
Method of measurement
Monitor Vital Signs
5
Description
Hemoglobin
Timepoint
Before, during and after surgery
Method of measurement
Blood sample
6
Description
Hematocrit and platelet
Timepoint
Before, during and after surgery
Method of measurement
Blood sample
Secondary outcomes
empty
Intervention groups
1
Description
The warmer will set at 40oC for the intervention group during surgery. The anesthesia protocol for both groups will consist of premedication with 0.05 mg/kg midazolam, induction by 5 mg/kg thiopental Sodium, 0.3 mg/kg atracurium, and 100% oxygen.
Category
Prevention
2
Description
Comparison group: The temperature in this group is 38 ° C
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Pars general hospital
Full name of responsible person
Giti Fotohi
Street address
No11, Saeedi Alley, Fereshteh St
City
Tehran
Province
Tehran
Postal code
1415944911
Phone
+98 21 8896 6052
Email
shchaichian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Kazem Malekoti
Street address
Research Deputy office of Iran University of Medical Sciences Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2703
Email
kmalakouti@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Valiolla Hasani
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6435 2107
Fax
Email
Hassani.v@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Valiolla Hasani
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6435 2107
Fax
Email
Hassani.v@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pars general hospital
Full name of responsible person
Giti Fotouhi
Position
Resident of Anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No11, saeedi Alley, fereshteh St
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8896 6052
Fax
Email
shchaichian@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available