The aim of this study is evaluation of the effect of ondansetron on decreasing the incidence of PDPH and related effects of ondansetron on nausea and vomiting, blood pressure and heart rate.
Two hundred and ten parturients who will undergo elective cesarean section under spinal anesthesia randomly will be allocated into two groups, in the intervention group, parturients will be received 0.15 mg/kg ondansetron in total volume of 2 ml. while, in the control group, parturients will be received 2ml normal saline. Heart rate, mean arterial pressure during surgery will be recorded. Incidence of nausea and vomiting and post operative headache will be followed by anesthesia nurses for 3 days in both groups and will be compared to each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013092111662N3
Registration date:2013-11-04, 1392/08/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-11-04, 1392/08/13
Registrant information
Name
Mohammad Ali Sahmeddini
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1231 8072
Email address
sahmeddini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellery of Research and Technology, Shiraz University Of Medical Sciences .
Expected recruitment start date
2013-11-23, 1392/09/02
Expected recruitment end date
2014-05-23, 1393/03/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey the effect of ondansetron on the postoperative headache in parturients undergoing cesarean section under spinal anesthesia.
Public title
The effects of ondansetron on reduction of the incidence of post spinal headache in parturients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclision Criteria: parturients who will candidate for elective cesarean section under spinal anesthesia .
Exclusion criteria: parturients with the history of cardiovascular disorder; taking antimigraine medications or selective serotonin reuptake inhibitors; hypersensitivity to ondansetron and local anesthetic drugs; those who have contraindication to do spinal anesthesia .
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
210
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
Shiraz University Medical Research Ethic Committee
Street address
Shiraz University of Medical Sciences ,Zand Blv
City
Shiraz
Postal code
197871345
Approval date
2013-09-22, 1392/06/31
Ethics committee reference number
CT-92-162
Health conditions studied
1
Description of health condition studied
Post dural puncture headach
ICD-10 code
029
ICD-10 code description
Spinal and epidural anaesthesia-induced headache during pregnancy
Primary outcomes
1
Description
Incidence of postdural puncture headach
Timepoint
1st day postoperation, 2nd day post operation, 3rd day postoperation.
Method of measurement
Clinical observation
Secondary outcomes
1
Description
Incidence of the nausea and vomiting
Timepoint
During surgery, 1st day postoperation
Method of measurement
Clinical observation
2
Description
Blood pressure and hear rate
Timepoint
Every 15 minutes during surgery
Method of measurement
Blood pressure: by sphygmomanomete, Heart rate : by electrocardiogram.
Intervention groups
1
Description
In the group O, before spinal anesthesia , parturients will be received intravenous (i.v) ondansetron 0.15 mg/kg diluted in 5 ml of normal saline .
Category
Treatment - Drugs
2
Description
In the control group parturients will be received 5 ml ormal saline before spinal anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Zainab Training and Medical Center
Full name of responsible person
Mohammad Ali Sahmeddini
Street address
Hazrat Zainab Training and Medical Center,Holy Defence Sq
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellery of Research and Technology
Full name of responsible person
Dr.Gholamreza Hatam
Street address
Vice-Chancellery of Research and Technology Department, 7th floor,Shiraz University Of Medical Sciences building
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellery of Research and Technology
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
Shiraz University Of Medical Sciences
Full name of responsible person
Mohammad Ali Sahmeddini
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Shiraz Anesthesiology and Critical Care Center, Namazi Hospital, Namazi Sq
City
Shiraz
Postal code
7193711351
Phone
+98 71 1647 4270
Fax
+98 71 1647 4270
Email
sahmeddini@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahmeddini
Position
Associate Professor of Anesthesiology دانشیار بیهوشی
Other areas of specialty/work
Street address
Shiraz Anesthesiology and Critical Care Center, Namazi Hospital, Namazi Sq
City
Shiraz
Postal code
7193711351
Phone
+98 71 1647 4270
Fax
+98 71 1647 4270
Email
sahmeddini@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
MohammadAli Sahmeddini
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Namazi Sq, Namazi Hospital, Shiraz Anesthesiologyand Critical Care Research
City
Shiraz
Postal code
7193711351
Phone
+98 71 1647 4270
Fax
+98 71 1647 4270
Email
sahmeddini@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)