Shivering is one of the most common intra and postoperative problems with a 20%-60% reported incidence. In addition to patient's discomfort, intra and postoperative hypothermia and shivering interfere with patent's monitoring and can increase oxygen consumption andCO2production. Recently serotonin receptor antagonists have been shown to be effective in the prevention of intra and postoperative shivering. The aim of this study is to evaluate the effect of Ondansetron in prevention of shivering in patients undergoing to cesarean section with spinal anesthesia with suggestion that prophylactic administration of this agent can prevent inta and postoperative shivering or reduce its severity.
After obtaining written informed consent for entering to study, one hundred pregnant patients scheduled for cesarean section, will be enrolled in two groups of 50 and received spinal anesthesia. Case or ondansetron group will be administered 4 mg ondansetron immediately after delivery and cord clamping and the control group will receive normal saline as placebo in the same volume (2 cc). The incidence and severity of inta and postoperative shivering will be checked and recorded according to Crossley and Mahjon scores. Shivering scores equal to or higher than 3 will be treated with 0.5 mg/kg IV Meperidine.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015020911700N6
Registration date:2015-06-29, 1394/04/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-29, 1394/04/08
Registrant information
Name
Farnaz Moslemi Tabrizi
Name of organization / entity
Alzahra hospital, Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
moslemif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2015-03-01, 1393/12/10
Expected recruitment end date
2016-03-01, 1394/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Ondansetrone for prevention of shivering during and after cesarean with spinal anesthesia
Public title
The effect of prophylactic administration of intravenous Ondansetron for control of shivering during and after spinal anesthesia for cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Pregnant women candidate for elective cesarean section with spinal anesthesia; ASA physical class I or II with informed consent for spinal anesthesia
Exclusion criteria:Patients with ASA physical class III or higher;preexisting cardiovascular diseases; respiratory diseases; preeclampsia or any hypetensive disorders during pregnancy;fever; any contraindication for performing spinal anesthesia
Age
From 18 years old to 44 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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 Vice chancellor for Research,Tabriz University Of Medical Sciences
Street address
Vice chancellor for Research,No.2 central building of Tabriz University Of Medical Sciences,Golgasht ave
City
Tabriz
Postal code
5138665793
Approval date
2015-01-12, 1393/10/22
Ethics committee reference number
93156
Health conditions studied
1
Description of health condition studied
Intra and post spinal anesthesia shivering
ICD-10 code
R68.0
ICD-10 code description
Hypothermia, not associated with low environmental temperature
2
Description of health condition studied
complications of anaesthesia
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia
Primary outcomes
1
Description
Incidence of intra and postoperative shivering
Timepoint
during surgery and in recovery
Method of measurement
Observation
2
Description
Severity of intra and postoperative shivering
Timepoint
during surgery and in recovery
Method of measurement
Crossly and Mahjon five-point scoring system
Secondary outcomes
1
Description
need for rescue tyreatment of shivering
Timepoint
during surgery and in recovery
Method of measurement
observation
Intervention groups
1
Description
Intervention:In this group ondansetron 4 mg iv and total volume of 2 ml was administered after neonatal delivery and clamping of the cord for prevention of intra and post-operative shivering .
Category
Prevention
2
Description
control group:In this group normal saline iv in total volume of 2 ml was administered as placebo after neonatal delivery and clamping of the cord .
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
AlzahraTeaching Hospital ,Tabriz University of Medical Sciences
Full name of responsible person
Dr Farnaz Moslemi
Street address
Alzahra Teaching Hospital, South Artesh ave.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Tabriz University Of Medical Sciences
Full name of responsible person
Dr Farnaz Moslemi
Street address
Vice chancellor for Research,No.2 Vice chancellor for Research,No.2 central building of Tabriz University Of Medical Sciences,golgasht ave
City
Tabriz
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, Tabriz 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
Research Center,Tabtiz University Of Medical Sciences
Full name of responsible person
Farnaz Moslemi
Position
Associated professore of Anesthesia,Anesthesiology
Other areas of specialty/work
Street address
Alzahra Hospital, Artesh Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
moslemifa@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Reaserch Center , Tabriz University of Medical Sciences
Full name of responsible person
Farnaz Moslemi
Position
Associated Professor of Anesthesia, Anesthesiologist
Other areas of specialty/work
Street address
Alzahra Hospital, Artesh Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 35539161
Fax
Email
moslemifa@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Farnaz Moslemi
Position
Associated Professore of Anesthesia, Anesthesiologist
Other areas of specialty/work
Street address
Alzahra Hospital, Artesh Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
moslemifa@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)