The effect of iIntravenous Injection of Serum temperature on hemoglobin saturation with oxygen, hemodynamic changes, shivering and postoperative recovery time in patients under general anesthesia and spinal anesthesia in subjects aged 16 to 55 years
Identifying and preventing postoperative complications
Design
Factorial and with blinded
Settings and conduct
The hospitals affiliated to the Babol University of Medical Sciences
Participants/Inclusion and exclusion criteria
People should be between the ages of 16 and 55 an undergo lower orthopedic surgery; The patient has Underlying problems such as obesity, vascular problems، pregnancy and anemia.
Intervention groups
Injection serum temperature
Main outcome variables
Have no consequences
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100908004715N2
Registration date:2019-01-19, 1397/10/29
Registration timing:registered_while_recruiting
Last update:2019-01-19, 1397/10/29
Update count:0
Registration date
2019-01-19, 1397/10/29
Registrant information
Name
Yosof Mortazavi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 4142
Email address
y.mortazavi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of iIntravenous Injection of Serum temperature on hemoglobin saturation with oxygen, hemodynamic changes, shivering and postoperative recovery time in patients under general anesthesia and spinal anesthesia in subjects aged 16 to 55 years
Public title
The effect of temperature of Intravenous Injection of Serum on postoperative shivering
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
All patient aged 16 to 55 years undergoing orthopedic surgery are lower extremity.
The patients surgery should last longer than 1 hour and be used for general anesthesia or spinal anesthesia.
Exclusion criteria:
The patient has Underlying problems such as obesity, vascular problems، pregnancy and anemia.
Age
From 16 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
In this project, 200 patients are selected as samples, divided into two equal groups of 100 general anesthesia and spinal anesthesia. Each group of 100 people is divided into two groups of 50 cases and controls.
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
The Ethics Committee of Babol University of Medical Sciences
Street address
Mazandaran, Babol, Ganj Afrouz Avenue, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2018-05-27, 1397/03/06
Ethics committee reference number
IR.MUBABOL.REC.1397.034
Health conditions studied
1
Description of health condition studied
Shivering after operation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hemoglobin saturation with oxygen, postoperative shivering and hemodynamic changes
Timepoint
In the first hour, every 15 minutes and up to 4 hours after surgery, every 1 hour once
Method of measurement
Warmers and thermocouple
Secondary outcomes
1
Description
Age and sex and type of anesthesia and patient body temperature
Timepoint
Before surgery
Method of measurement
Through the questionnaire
Intervention groups
1
Description
In this study, 100 patients between the ages of 16 and 55 undergoing lower limb orthopedic surgery with general anesthesia or spinal anesthesia, with the duration of surgery of more than one hour, were randomly assigned to two groups of 50. The first group, including the general anesthesia group, and spinal anesthesia, with angiocath No18 through the elbow vein of the 1 ml of blood loss 3 ml dextrose saline crystalloid, plus 2 ml per kg body weight, is injected as a preservative dose from the same dextrose saline crystalloid. Blood is also prescribed if the patient's bleeding is more than 15% of the body's blood volume. Liquids administered to the patient (serum and blood) are injected through a fluid heater (warmer) at 37 C.
Category
Prevention
2
Description
In this study, 100 patients between the ages of 16 and 55 undergoing lower limb orthopedic surgery with general anesthesia or spinal anesthesia, with the duration of surgery of more than one hour, were randomly assigned to two groups of 50. The first group, including the general anesthesia group, and spinal anesthesia, with angiocath No18 through the elbow vein of the 1 ml of blood loss 3 ml dextrose saline crystalloid, plus 2 ml per kg body weight, is injected as a preservative dose from the same dextrose saline crystalloid. Blood is also prescribed if the patient's bleeding is more than 15% of the body's blood volume. With the exception that in the control group, the dextrose saline crystalloid and the blood may be administered at the same operating temperature (22 C). After the operation, Intervention and control group evaluated for the Hemoglobin saturation with oxygen, hemodynamic changes, shivering and recovery time. The operation temperature is checked by thermometer.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Mr.Akbar Zadeh
Street address
Ganj Afrouz Avenue, Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3220 8143
Email
y.mortazavi@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Jalali
Street address
Ganj Afrouz Avenue, Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3220 8143
Email
y.mortazavi@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Babol University of Medical Sciences
Full name of responsible person
Yousef Mortazavi
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Babol university of medical sciences
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3220 8143
Email
Y.mortazavi@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Yousef Mortazavi
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Babol university of medical sciences
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3220 8143
Email
Y.mortazavi@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
yousef mortazavi
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Ganj afroz street
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 5520
Email
mortazavi1337@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After completing the project, all information will be provided
When the data will become available and for how long
At least two months after the completion of the project
To whom data/document is available
All employees and students at hospitals and medical universities
Under which criteria data/document could be used
After asking the parson and confirming all the executives of the project
From where data/document is obtainable
Send mail to the messenger
What processes are involved for a request to access data/document
After sending an email, administrators can respond whithin a maximum of two weeks to one month