Purpose: The purpose of this study is to Compare of oral and intravenous ondansetron in the prevention of postoperative nausea and vomiting in cesarean section with spinal anaesthesia.Plan: This is a randomized, double-blind, with placebo and clinical trial phase II study.Inclusion criterion: patients who were candidates for cesarean section with spinal anaesthesia.Exclusion criteria: patients who had more than two failure in spinal anaesthesia and had a history of postoperative nausea and vomiting, history of motion sickness, history of allergy to ondansetron, history of hyperemesis gravidarum. The sample size in this study is 162.Interventions: all patients underwent spinal anesthesia and patient in group one recived 8 mg(two tablet) ondansetron orallry 30 minutes before surgery and recived 2 ml Distilled water intravenously after spinal anesthesia, in group two recived two tablets as same as ondansetron 30 minutes before surgery and recived intravenous 4 mg (2 cc) ondansetron after spinal anesthesia and in group three recived two tablets as same as ondansetron 30 minutes before surgery and recived 2 ml Distilled water intravenously after spinal anesthesia.Primary outcome:in 0,1,2,4,6 hours after arrive to recovery "nausea and vomiting" and " level of consciousness" were recorded
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212162080N13
Registration date:2013-06-19, 1392/03/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-19, 1392/03/29
Registrant information
Name
Afsaneh Norouzi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1313 7474
Email address
norouzi.a@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences,Vice chancellor for research
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-06-18, 1392/03/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral and intravenous ondansetron in the prevention of postoperative nausea and vomiting in cesarean section with spinal anesthesia
Public title
Comparison of oral and intravenous ondansetron in the prevention of postoperative nausea and vomiting in cesarean section with spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18-45 and ASA Class I and II
Exclusion criteria:
history of postoperative nausea and vomiting; history of motion sickness; history of allergy to ondansetron; more than two failure in spinal anaesthesia;
history of hyperemesis gravidarum.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
162
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
Ethical Committee of Arak University of Medical Sciences
Street address
Alamolhoda Ave, Arak University of Medical Sciences
City
arak
Postal code
Approval date
2012-11-26, 1391/09/06
Ethics committee reference number
91-137-2
Health conditions studied
1
Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Nausea and vomiting
Timepoint
At 0, 1, 2, 4 and 6 hours after arrive to recovery
Method of measurement
Clinical assesment
2
Description
Consciousness
Timepoint
At 0, 1, 2, 4 and 6 hours after arrive to recovery
Method of measurement
Using Ramsay score
Secondary outcomes
empty
Intervention groups
1
Description
In group one, patients recived 8 mg(two tablet) ondansetron orallry 30 minutes before surgery and recived 2 ml Distilled water intravenously after spinal anaesthesia
Category
Prevention
2
Description
In group two, patients recived two tablets as same as ondansetron 30 minutes before surgery and recived intravenous 4 mg (2 cc) ondansetron after spinal anaesthesia
Category
Prevention
3
Description
In group three, patients recived two tablets as same as ondansetron 30 minutes before surgery and recived 2 ml Distilled water intravenously after spinal anaesthesia
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Talghani hospital
Full name of responsible person
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences,Vice chancellor for research
Full name of responsible person
Dr Saeed Changizi Ashtiani
Street address
Arak University Of Medical Science, Basij Square
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences,Vice chancellor for research
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
Arak University of Medical Sciences
Full name of responsible person
Dr Afsaneh Norouzi
Position
Assistant professor, anesthesiologist
Other areas of specialty/work
Street address
Valiasr hospital
City
Arak
Postal code
Phone
+98 86122247900
Fax
Email
norouzi.a@arakmu.ac.ir; norouzi43@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Afsaneh Norouzi
Position
Anesthesiologist, assistant professor
Other areas of specialty/work
Street address
Vali-Asr hospital
City
Arak
Postal code
Phone
+98 86 1222 4790
Fax
Email
norouzi.a@arakmu.ac.ir; norouzi43@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Afsaneh Norouzi
Position
Anesthesiologist, assistant professor
Other areas of specialty/work
Street address
Vali-Asr hospital
City
Arak
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)