Comparison the effect of forced air warming and warmed intravenous fluid on comfort and prevention of shivering after spinal anesthesia in patient undergoing orthopedic surgery
Comparison the effect of forced air warming and warmed intravenous fluid on comfort and prevention of shivering after spinal anesthesia in patient undergoing orthopedic surgery
Design
A clinical trial with a control group, with parallel groups,single
Blind , randomized
Settings and conduct
The present study will be performed in Kashan Naghavi Hospital operating room. Patients referred to the operating room of the lower extremity for orthopedic surgery will be randomly divided into three groups: hot air pressure (40 patients), warm venous serum (40 patients) and control group (40 patients). The first group will receive the serum at room temperature (21-23 ° C) and warm air at 38 ° C. For the second group, the warm serum will be infused at 37 ° C. The third group is the control group, which will be routinely monitored for serum and room temperature (21-23 ° C).
Participants/Inclusion and exclusion criteria
Patients undergoing orthopedic surgery - age 18-60 years - under spinal anesthesia
Intervention groups
Group A ( using of forced air warming 38° C)
Group B (using warm intravenous serum at 37° C)
Group C (The control group will be routinely monitored for serum and room temperature)
Main outcome variables
Reduce shivering during surgery, reduce drug side effects, earlier discharge, reduce anxiety, reduce hospital costs.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191224045885N1
Registration date:2020-01-12, 1398/10/22
Registration timing:prospective
Last update:2020-01-12, 1398/10/22
Update count:0
Registration date
2020-01-12, 1398/10/22
Registrant information
Name
Mehdi Moheb
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5543 4556
Email address
mehdi.moheb8445@mailfa.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-05, 1398/12/15
Expected recruitment end date
2020-06-04, 1399/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of forced air warming and warmed intravenous fluid on comfort and prevention of shivering after spinal anesthesia in patient undergoing orthopedic surgery
Public title
The effect of forced air warming and warmed intravenous fluid on comfort and prevention of shivering
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Having orthopedic surgery in the lower limb and under spinal anesthesia
Having the consent to participate in the study
Patients who are in Class 1 and 2 according to the American Anesthesiological Association (ASA)
Patients 18-60 years old
No corticosteroid drugs and NSAIDs taken 24 hours before surgery
Exclusion criteria:
Blood injection and blood products during surgery
Conversion of spinal anesthesia to general anesthesia during surgery due to insufficient surface area and severity of anesthesia
The temperature of the tympanic membrane is less than 36.5 and greater than 37.5 ° C
Increased spinal anesthesia
Duration of surgery more than 3 hours
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into 6 groups and divided into three groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, all three groups of participants were kept blind. Patients will be told that the study is intended for your well-being so that they will experience comfortable environmental surgery.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
15 Khordad Square, Municipality street
City
Kashan
Province
Isfehan
Postal code
8715973474
Approval date
2019-06-30, 1398/04/09
Ethics committee reference number
IR.Kaums.nuhepm.rec.1398.022
Health conditions studied
1
Description of health condition studied
Patients undergoing orthopedic surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Patients' shivering based on quadratic scale: No shiver 0; Mild shiver: Mild contractions in facial and neck muscles (1); Moderate shiver: Apparent shivering in neck and shoulders and extremities (2); Severe shivering: Apparent shivering They will be evaluated throughout the body (3)
Timepoint
On arrival before spinal (0 minutes), 15 minutes after spinal, surgical completion time, recovery time, and 15 minutes after surgery
Method of measurement
Quadruple shivering Scale
Secondary outcomes
1
Description
Patients' comfort ratings will be scored based on a VAS observation score ranging from 0 to 10. (0 indicates patient satisfaction with temperature and temperature; and 10 indicates worst patient perception of temperature and temperature conditions )
Timepoint
On arrival before spinal (0 minutes), 15 minutes after spinal, surgical completion time, recovery time, and 15 minutes after surgery
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group: The first group of serum recipients will be operated at room temperature (21-23 ° C) and hot air at 38 ° C (Warm Touch; Mallinckrodt Medical, St Louis, MO, USA).
Category
Prevention
2
Description
Intervention group: For the second group, 37 ° C warm serum kept in the heater prior to infusion (Fan Azma Gostar.CO, Iran; Thermometer Industrial Group) to reach 37 ° C during infusion.
Category
Prevention
3
Description
Control group: The third group is the control group that will be under routine care of serum and room temperature (21-23 ° C).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi Hospital
Full name of responsible person
Firouzian Ali
Street address
Rajai Street
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5545 1515
Email
info@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Alireza Moravji
Street address
15 Khordad Square, Municipality street
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Email
info@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
80
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
Kashan University of Medical Sciences
Full name of responsible person
Moheb Mehdi
Position
Anesthesiologist
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Bustan Blvd
City
Kashan
Province
Isfehan
Postal code
8719334801
Phone
+98 31 5543 4556
Email
mehdi.moheb8445@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Rezai Mahboubeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Rajai Street
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5554 0021
Email
m4.rezaei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Moheb Mehdi
Position
Anesthesiologist
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Bustan Blvd
City
Kashan
Province
Isfehan
Postal code
8719334801
Phone
+98 31 5543 4556
Email
mehdi.moheb8445@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
All potential data can be shared after unidentifiable people.
When the data will become available and for how long
Start access period 7 months after publishing results.
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Compliance with the rules is not a restriction on the use of data.
From where data/document is obtainable
Kashan University of Medical Sciences-Tel: 03155540021 Email: info@kaums.ac.ir
What processes are involved for a request to access data/document
Access period starting from September 1999 through Kashan University of Medical Sciences