Determining the effect of two methods of peri-operative active warming on abdominal surgery patients’ mean core temperature
Design
The number of samples was selected according to the criteria for inclusion and exclusion . After obtaining the informed conscientious consent of the patients to participate in the research using software, they are randomly divided into three groups (2 intervention and 1 control).
Settings and conduct
The randomized clinical trial، in the operating room department of fatemehalzahra hospital of Mehriz
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidate patients for elective abdominal surgery under general anesthesia
Age range 18-75 years
Body mass index in the range of 20-30
ASA risk:I-III
exclusion criteria: Body temperature bellow 36 centigrade degree
Existence of metabolic diseases, Infection or temperature outside the normal range in the three days before surgery (fever)
History of known thyroid disease
History of drug use
Taking corticosteroids or non-steroidal anti-inflammatory drugs
Blood transfusion during surgery
Intervention groups
Intervention group 1:This semi- experimental study was performed on 180 candidates for elective abdominal surgery by general anesthesia referring to the operating room fatemaalzahra (Mehriz) Hospital in 1399. 60 patients will are subjected to Peri - operative warming by adjusting the electrical blanket temperature by 40 degrees below the body surface. intervention group 2 warmed infusion and irrigation fluid are used and control group receive routine care.
Main outcome variables
central body temperature
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200904048613N1
Registration date:2022-03-02, 1400/12/11
Registration timing:retrospective
Last update:2022-03-02, 1400/12/11
Update count:0
Registration date
2022-03-02, 1400/12/11
Registrant information
Name
Mahboubeh Zareian baghdadabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3252 4918
Email address
mahboubeh.zareian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2021-05-10, 1400/02/20
Actual recruitment start date
2020-04-03, 1399/01/15
Actual recruitment end date
2021-05-10, 1400/02/20
Trial completion date
2021-05-10, 1400/02/20
Scientific title
Comparing the study of the effect of two methods of Peri-operative active warming on abdominal surgery patients’ mean core temperature
Public title
Investigating the effect of two methods of peri-operative active warming on abdominal surgery patients’ mean core temperature
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Elective patients undergoing abdominal surgery under general anesthesia with a mean age of 18-75
Exclusion criteria:
If the central temperature is bellow 36 and above 37.5 centigrade degree
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
180
Actual sample size reached:
180
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 180 qualified patients selected. First, using Random allocation software version 1 and block random allocation method, we determined the random sequence for numbers 1 to 180. The samples to each of the two intervention groups (receiving infusion and irrigation fluids and warming patients with electric blankets under their body surface) and the control group were randomly assigned in 3 block for each patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to consider blinding, the intervention are performed by a researcher's assistant and the research are completed by the researcher.the researcher didn't know to which groups patients were assigned and the responsible experts in anesthesia and surgical technicians did not inform the patients’ classification in each group.
Placebo
Not used
Assignment
Other
Other design features
doesn't have
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Faculty of Nursing and Midwifery school, Bouali Alley, Teamsar Fallahi st, Safaee, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
916877443
Approval date
2020-05-17, 1399/02/28
Ethics committee reference number
ir.ssu.rec.1399.039
Health conditions studied
1
Description of health condition studied
patients undergoing elective abdominal surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
central body temperature
Timepoint
pre anesthesia - during anesthesia - after surgery
Method of measurement
Based on degrees C and using the tympanic thermometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1:This semi- experimental study was performed on 180 candidates for elective abdominal surgery by general anesthesia referring to the operating room fatemaalzahra (Mehriz) Hospital in 1399. 60 patients will are subjected to Peri - operative warming by adjusting the electrical blanket temperature by 40 degrees below the body surface
Category
Prevention
2
Description
Intervention group2:warming infusion and irrigation fluid by 38 degree during surgery