The aim of this study is the comparison of Diclofenac NA suppository and intravenous hydrocortisone on shivering after cesarean section surgery. Design: It is a double-blind randomized clinical trial study in Kowsar teaching hospital.nSetting and conduct: aforementioned drugs administered 10 minutes before spinal anesthesia and tympanic temperature, mean arterial pressure, pulse rate and shivering severity will be recorded 10 minute before intrathecal injection in recovery room, at the end of operation and every 30 minutes until 1 hour. Participants: 150 physical status 1 pregnant women, scheduled for elective cesarean section enroll in this study and they will be excluded if they have a history of asthma; peptic ulcer; renal, hepatic or hemorrhagic diseases. Interventions: First group receive Diclofenac NA suppository and normal saline, second group receive intravenous Hydrocortisone and placebo suppository and third group receive intravenous normal salin and placebo suppository. Main outcome measure variable: Shivering
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201602273051N6
Registration date:2016-09-20, 1395/06/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-20, 1395/06/30
Registrant information
Name
Marzieh Khezri
Name of organization / entity
Qazvine University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1223 6376
Email address
mkhezri@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Qazvin University of Medical Science and Health Services
Expected recruitment start date
2016-09-05, 1395/06/15
Expected recruitment end date
2017-01-04, 1395/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Diclofenac NA and hydrocortisone on shivering in patients undergoing cesarean section under spinal anesthesia
Public title
The effect of Diclofenac NA and hydrocortisone on shivering
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women who candidate for elective cesarean section; ASA class 1, 2.
Exclusion criteria: history of asthma; peptic ulcer; febrile disease, or endocrine disease; addiction to opioid; smoking; consumption of steroids; consumption of NSAIDS or other analgesics.
Age
From 17 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
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
Ethics committee of Qazvin University of Medical Sciences
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Postal code
Approval date
2013-11-25, 1392/09/04
Ethics committee reference number
28/20/8104
Health conditions studied
1
Description of health condition studied
Complications predominantly related to the anesthesia
ICD-10 code
089.5
ICD-10 code description
Other complications of spinal and epidural anaesthesia
Primary outcomes
1
Description
shivering
Timepoint
10 min before anesthesia, after surgery and every 30 minute until an hour.
Method of measurement
observation and medical records
Secondary outcomes
1
Description
Temperature
Timepoint
10 min before anesthesia, after surgery and every 30 minute until one hour
Method of measurement
Thermometery from tympanic membrane
2
Description
Blood pressure
Timepoint
10 min before anesthesia, after surgery and every 30 minute until one hour
Method of measurement
With manonetery from brachial artery
3
Description
Pulse rate
Timepoint
10 min before anesthesia, after surgery and every 30 minute until one hour
Method of measurement
With monitoring
Intervention groups
1
Description
Intervention 1: First group receive placebo Supp. and 2cc of IV hydrocortison, 10 min before anesthesia.
Category
Prevention
2
Description
Intervention 2: Second group receive 100mg Diclofenac supp and 2cc of normal saline, 10 min before anesthesia .
Category
Prevention
3
Description
Intervention 3: Third group receive placebo Supp and 2cc of IV normal saline, 10 min before anesthesia .
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Dr. Marziyeh Beigom Khezri
Street address
Kowsar Hospital, Taleghani street, Qazvin, Iran
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Qazvin University of Medical Sciences
Full name of responsible person
Dr. Naser Taghipoor Farivar
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
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 of Qazvin University of Medical Sciences