Clinical trial comparing the effect of using warm serums and non-heated serums during surgery on hypothermia, postoperative shivering and pain in patients after orthopedic surgery in lower extremities
Aim of this study is survey effect of warm infusion serum and warm irrigation serum during surgery on postoperative hypothermia, shivering and pain in patients after major orthopedic surgery in lower extremities.
Patients who administered for orthopedic surgery in lower extremities and have not any infection and metabolism disorders before surgery randomly assign in two groups. Sample size will be estimated after the pilot study. Patients in intervention group, will be received warm infusion serum and warm irrigation serum with temperature of 37.5 °C. Patients in control group will be received infusion serum and irrigation serum with temperature equal of operation room. Body temperature during surgery and at the end of recovery and severity of shivering in recovery room will be measured. Pain severity of surgical site in the first day will be measured every six hours. Then body temperature, severity of shivering and pain severity of patients in two groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052032361N2
Registration date:2017-06-26, 1396/04/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-26, 1396/04/05
Registrant information
Name
Hojjat Torkmandi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 263601135
Email address
torkmandi.or@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-08-22, 1397/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparing the effect of using warm serums and non-heated serums during surgery on hypothermia, postoperative shivering and pain in patients after orthopedic surgery in lower extremities
Public title
Effect of using warm serums during surgery on post operative complications in patients after major orthopedic surgery in lower extremities
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: American society of anesthesiologist physical status class I or II; Age between 18 and 80 years; Time of surgery between 2 and 3 hours;
Exclusion criteria: History of thyroid diseases; diabetes; infection before surgery; body Mass Index more than 35; temperature lower than 36°C and higher than 38°C before surgery; open fractures; blood transfusion during surgery; history of addiction; history of any orthopedic surgery in last month ago.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
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
Semnan University of Medical Sciences
Street address
Nursing faculty, Semnan University of Medical Sciences, 5th Km of Damghan Road
City
Semnan
Postal code
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.SEMUMS.REC.1396.65
Health conditions studied
1
Description of health condition studied
Hypothermia
ICD-10 code
T68
ICD-10 code description
T88.5
Primary outcomes
1
Description
Body temprature
Timepoint
Immediately after induction, 15 min after anesthesia, 30 min after anesthesia ,60 min after anesthesia and 120 min after anesthesia and at the end of surgery and in recovery room.
Method of measurement
By using tympanic thermometer Micro life IR100
Secondary outcomes
1
Description
Severity of shivering
Timepoint
In recovery room, every 15 min
Method of measurement
Shivering scale, every patient will be received score between 0 and 3
2
Description
Severity of pain
Timepoint
In the first day after surgery every 6 hours.
Method of measurement
By using of Visual Analog Scale (VAS) between 0-10
Intervention groups
1
Description
Intervention group: All patients will be received intravenous and irrigation serum with temperature of 37.5 °C during the surgery.
Category
Prevention
2
Description
Control group: All patients will be received intravenous and irrigation serum with temperature equal of operating room.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhtar hospital
Full name of responsible person
Hojjat torkmandi
Street address
Akhtar hospital, Sharifi manesh St, Elahieh
City
Tehran
2
Recruitment center
Name of recruitment center
Shahid Madani hospital
Full name of responsible person
Hojjat torkmandi
Street address
Shahid Madani hospital, North Taleghani Blv, Shahrak Edari
City
Karaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Rashydipoor
Street address
Semnan University of Medical Sciences, End of Basij Avenue, Semnan, Iran.
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
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
Semnan University of Medical Sciences
Full name of responsible person
Hojjat Torkmandi
Position
Student Master of critical care nursing
Other areas of specialty/work
Street address
Nursing faculty, Semnan University of Medical Sciences, 5th km Damghan road, Semnan, Iran.
City
Semnan
Postal code
Phone
+98 23 3365 4191
Fax
Email
hojjat.or@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of medical Sciences
Full name of responsible person
Hesamodin Askari Majdabadi
Position
Ph.D in Health Education and Promotion
Other areas of specialty/work
Street address
Nursing faculty, Semnan University of Medical Sciences, 5th Km Damghan road
City
Semnan
Postal code
Phone
+98 23 3333 4190
Fax
Email
hesamaskari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hojjat Torkmandi
Position
Student master of critical care nursing
Other areas of specialty/work
Street address
Nursing faculty, Semnan University of Medical Sciences, 5th Km Damghan road
City
Semnan
Postal code
Phone
+98 23 3365 4191
Fax
Email
hojjat.or@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)