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Comparison of the efficacy of two methods of warming on patient in abdominal surgery on physiologic parameters and shivering in hamedan´s besat hospital in 1392

Protocol summary

Summary
Objective: Comparison of the efficacy of two methods of warming on patient in abdominal surgery on physiologic parameters and Postoperative shivering. Study design : Stratified random sampling. Study population: patients with abdominal surgery in Besat Hospital in Hamadan. The main criteria for inclusion: patients without underlying diseases such as hypothyroidism, hyperthyroidism, diabetes, hypertension and Cardiovascular disease, no fever, aged between 18 and 65 years, abdominal surgery under general anesthesia up to 3 hours. Main exclusion criteria: the need for blood transfusions during surgery, intra-abdominal infections, Allergy to general anesthetics drugs, Receiving sedation. Sample size: 132 patients. Intervention or interventions studied: in each group, patients will have a warming approach. Intervention Time: In a group 15 minutes before induction of anesthesia, Patient's trunk and lower extremitiesis heated by a warmer and in other group immediately after induction of anesthesia, the patients body covered by a layer of cotton cover and Laminated Fabric to prevent heat loss, design variables before induction, after induction and then every 15 minutes until patient discharge from the recovery will be measured. shivering and grading the severity of shivering in the recovery room by a trained nurse who does not know the type of intervention will be evaluated by an observational tool (Grossely and Mahajan). Primary outcome: changes in physiological parameters and reducing shivering

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013092114722N1
Registration date: 2013-10-28, 1392/08/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-10-28, 1392/08/06
Registrant information
Name
Sudabe Asadi
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1262 9801
Email address
s.asadi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of two methods of warming on patient in abdominal surgery on physiologic parameters and shivering in hamedan´s besat hospital in 1392
Public title
Comparison of the efficacy of two methods of warming on patient in abdominal surgery on physiologic parameters and shivering in hamedan´s besat hospital in 1392
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: abdominal surgery with opening of the peritoneal cavity; Age 18-65 years; abdominal surgery under general anesthesia up to 3 hours; not receiving corticosteroids, nonsteroidal analgesics and anti-hypertensive drugs; Lack of infection; Non-emergency abdominal surgery (elective surgery or urgent); patients without underlying diseases such as hypothyroidism, hyperthyroidism, diabetes, hypertension and Cardiovascular disease. Exclusion criteria: Allergy to drugs used in general anesthesia; The need for blood transfusions during surgery; Patients who require Intravenous fluids during surgery More than the Fluid therapy protocol; Receive a Analgesic and sedative medication before anesthesia induction; Receive a sedative medication in recovery room; patients who have evidence of intra-abdominal infections after opening the abdominal wall.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 132
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street, Hamadan
City
Hamadan
Postal code
65178
Approval date
2013-09-09, 1392/06/18
Ethics committee reference number
1689/9/35/16/پ

Health conditions studied

1

Description of health condition studied
Post operative shivering
ICD-10 code
t88.5
ICD-10 code description
Other complications of anaesthesia

Primary outcomes

1

Description
Shivering
Timepoint
Post operative
Method of measurement
Visual assessment scale

2

Description
Blood pressure
Timepoint
Before induction of anesthesia, immediately after induction of anesthesia and then every 15 minutes until patient discharge from the recovery
Method of measurement
Sphygmomanometer

3

Description
Core body temperature
Timepoint
Before induction of anesthesia, immediately after induction of anesthesia and then every 15 minutes until patient discharge from the recovery
Method of measurement
Tympanic thermometer

4

Description
Saturation of O2
Timepoint
Before induction of anesthesia, immediately after induction of anesthesia and then every 15 minutes until patient discharge from the recovery
Method of measurement
Pulse oximetry

5

Description
Pulse rate
Timepoint
Before induction of anesthesia, immediately after induction of anesthesia and then every 15 minutes until patient discharge from the recovery
Method of measurement
Hemodynamic Monitor

6

Description
Respiratory rate
Timepoint
Before induction of anesthesia, immediately after induction of anesthesia and then every 15 minutes until patient discharge from the recovery
Method of measurement
Enumeration

Secondary outcomes

1

Description
time of shivering
Timepoint
Postoperative
Method of measurement
Observation

2

Description
The amount of administered fluids
Timepoint
Postoperative
Method of measurement
Observation

3

Description
Duration of surgery
Timepoint
Postoperative
Method of measurement
The onset of anesthesia until the end of anesthesia

Intervention groups

1

Description
In one group 15 minutes before induction of anesthesia, the patient's trunk and lower extremities is heated by a heating warmer
Category
Prevention

2

Description
In another group immediately after induction of anesthesia, patients body covered by a layer of cotton cover and laminated fabrics to prevent heat loss
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Hamadan's Besat Hospital
Full name of responsible person
Sudabe Asadi, MSc Student in Critical Care Nursing
Street address
Besat Hospital, Motahari Blv, Hamadan
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Heidar Tavilani
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street, Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Sudabe Asadi
Position
MSc Student in Critical Care Nursing
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street, Hamadan
City
Hamadan
Postal code
Phone
+81 12629801
Fax
Email
s.asadi@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr Nahid Manochehrian
Position
Anesthesiologist
Other areas of specialty/work
Street address
Hamadan, Besat Hospital
City
Hamadan
Postal code
Phone
+98 81 1264 0045
Fax
Email
nmanuchehrian@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Sudabe Asadi
Position
MSc Student in Critical Care Nursing
Other areas of specialty/work
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street, Hamadan
City
Hamadan
Postal code
Phone
+98 81 1262 9801
Fax
Email
s.asadi@umsha.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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