1. Home
  2. Approved trials
  3. » فارسی

Comparison of intravenous infusion of warm saline and dexamethasone in the prevention of postoperative shivering

Protocol summary

Summary
Objectives: The aim of this study was to compare one medication and one non-medication method used for controlling post operative shivering. Design: A total of 120 patients whose physical status met the criteria of American society of Anesthesiologists, were aged 20 to 50 years, underwent elective surgery (surgical operations other than laparotomy, orthopedic, ENT), and had GA were randomly divided into three groups. Setting and intervention: After general anesthesia, warm saline was applied for the patients in group 1 (n=40), 0.15 mg per kg Dexamethasone was applied for the patients in group 2 (n=40), and saline (22 to 24 C) was applied for the patients in group 3 (n=40). The tympanic temperature was evaluated pre-operatively and intra-operatively and post-operatively. Inclusion criteria for the group I and II were the followings: laparoscopic surgery under general anesthesia, surgery, ENT surgery and eye surgery, being aged 20 to 50 years, avoiding the use of corticosteroids, non-steroidal analgesics, magnesium sulfate and blood pressure medications, no fever, no addiction, normal body temperature (the temperature of 36.5 to 37.5), as well as the physical class of ASA (American Society of Anesthesiology). Exclusion criteria also included the followings: emergency surgery, blood transfusion during surgery, surgery lasting more than two hours, neuromuscular disease, low blood pressure during surgery for any reason that required more fluid intake or changed the calculation program, and taking medical and non-medical anesthetic drugs. Main outcome measures: Shivering was evaluated and recorded post-operatively.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015041721806N1
Registration date: 2015-07-21, 1394/04/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-07-21, 1394/04/30
Registrant information
Name
Abolfazl Abdollahpoor
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 532 6300
Email address
abolfazlabdollahpoor@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravenous infusion of warm saline and dexamethasone in the prevention of postoperative shivering
Public title
Comparison of intravenous infusion of warm saline and dexamethasone in the prevention of postoperative shivering
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria for the group I and II were the followings: laparoscopic surgery under general anesthesia, surgery, ENT surgery and eye surgery, being aged 20 to 50 years, avoiding the use of corticosteroids, non-steroidal analgesics, magnesium sulfate and blood pressure medications, no fever, no addiction, normal body temperature (the temperature of 36.5 to 37.5), as well as the physical class of ASA (American Society of Anesthesiology). Exclusion criteria also included the followings: emergency surgery, blood transfusion during surgery, surgery lasting more than two hours, neuromuscular disease, low blood pressure during surgery for any reason that required more fluid intake or changed the calculation program, and taking medical and non-medical anesthetic drugs.
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
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
Semnan University of Medical Sciences, Basij bolvar
City
Semnan
Postal code
Approval date
2015-03-17, 1393/12/26
Ethics committee reference number
479/94

Health conditions studied

1

Description of health condition studied
Postoperative shivering
ICD-10 code
T88.9
ICD-10 code description
Complication of surgical and medical care, unspecified

Primary outcomes

1

Description
Shivering
Timepoint
On arrival the patient to the operating room, anesthesia beginning, the end of the anesthesia, the beginning of recovery and the recovery
Method of measurement
Thermometer

Secondary outcomes

1

Description
Hemodynamics( Blood presure)
Timepoint
On arrival the patient to the operating room, anesthesia beginning, the end of the anesthesia, the beginning of recovery and the recovery
Method of measurement
Cuff pressure monitoring device

Intervention groups

1

Description
After general anesthesia, warm saline was applied for the patients in group 1 (n=40), 0.15 mg/kg Dexamethasone was applied for the patients in group 2 (n=40), and saline (22 to 24 C) was applied for the patients in group 3 (n=40). The tympanic temperature was evaluated pre-operatively and intra-operatively and post-operatively. Shivering was evaluated and recorded post-operatively.
Category
Treatment - Drugs

2

Description
The placebo control group received distilled water and serum samples at room temperature (22-20 ° C) via infusion.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar hospital
Full name of responsible person
Abolfazl Abdollahpoor
Street address
St. Amin
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Semnan University of Medical Sciences
Street address
Vice chancellor for research, Semnan University of Medical Sciences
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
Abolfazl Abdaollahpoor
Position
Anesthesiologist
Other areas of specialty/work
Street address
Kosar hospita, Semnanl
City
Semnan
Postal code
Phone
+98 912 532 6300
Fax
Email
abolfazlabdollahpoor@semums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Abolfazl Abdollahpoor
Position
Anesthesiologist
Other areas of specialty/work
Street address
Kosar hospita, Semnanl
City
Semnan
Postal code
Phone
+98 912 532 6300
Fax
Email
abolfazlabdollahpoor@semums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Abolfazlabdollahpoor
Position
Anesthesiologist
Other areas of specialty/work
Street address
kosar hospital
City
Semnan
Postal code
Phone
+98 989125326300
Fax
Email
abolfazlabdollahpoor@semums.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
Loading...