Comparison the effect of oral Gabapentin and oral ondansetron and oral Ginger to prevention nausea and vomiting after cesarean section by spinal anesthesia
Aim of research is Comparison the effect of oral Gabapentin and oral ondansetron and oral Ginger to prevention nausea and vomiting after cesarean section by spinal anesthesia. The method of research is randomized double blind placebo controlled clinical trial. Study population are pregnant women who come to Arak Taleghani Hospital for elective cesarean section . Inclusion criteria: age18-45; candidate for elective cesarean section by spinal anesthesia.Exclusion criteria: Motion Sickness: sensitivity to Gabapentin and ondansetron and l Ginger;trial more than 2 times for spinal anesthesia.208 women randomly divided in 4 groups( intervention and control). One group (52 person) received capsule Gabapentin 300 mg.Second group (52 person)receive capsule ondansetron 8 mg .Third group receive capsule ginger 1 g.Forth group receive capsule placebo.Before intervention and 1,2,4,6 hour after intervention measure nausea and vomiting.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201401014686N10
Registration date:2014-01-03, 1392/10/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-03, 1392/10/13
Registrant information
Name
Mehri Jamilian
Name of organization / entity
School of Medicine, Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1278 0660
Email address
mjamilian@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences ,vice president of education and research
Expected recruitment start date
2013-12-24, 1392/10/03
Expected recruitment end date
2014-05-24, 1393/03/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of oral Gabapentin and oral ondansetron and oral Ginger to prevention nausea and vomiting after cesarean section by spinal anesthesia
Public title
Comparison the effect of oral Gabapentin and oral ondansetron and oral Ginger to prevention nausea and vomiting after cesarean section by spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age18-45; candidate for elective cesarean section by spinal anesthesia.
Exclusion criteria: Motion Sickness: sensitivity to Gabapentin and ondansetron and Ginger;trial more than 2 times for spinal anesthesia.
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:
208
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Basij Square
City
Arak
Postal code
Approval date
2013-12-24, 1392/10/03
Ethics committee reference number
92-155-2
Health conditions studied
1
Description of health condition studied
nausea and vomiting after cesarean section by spinal anesthesia
ICD-10 code
O29.5
ICD-10 code description
Other complications of anaesthesia during pregnancy
Primary outcomes
1
Description
nausea and vomiting
Timepoint
1,2,4,6 hour after intervention
Method of measurement
quadruplicate score
Secondary outcomes
1
Description
drug side effect
Timepoint
1,2,4,6 after intervention
Method of measurement
quadruplicate score
Intervention groups
1
Description
First group (52 person )capsule gabapentin 300mg.
Category
Treatment - Drugs
2
Description
Second group (52 person) receive capsule ondansetron 8 mg.
Category
Treatment - Drugs
3
Description
Third group (52 person) receive capsule ginger 1 g.
Category
Treatment - Drugs
4
Description
Fourth group (52 person ) receive capsule placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak University of Medical Sciences
Full name of responsible person
Dr.Mehri Jamilian
Street address
Taleghani Hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.Ashtiyani
Street address
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
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
Mehri Jamilian
Position
Board of Obstetric
Other areas of specialty/work
Street address
Thaleghani Hospital
City
Arak
Postal code
3819691187
Phone
+98 86 3278 0660
Fax
Email
mjamilian@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehri Jamilian
Position
Board of Obstetric
Other areas of specialty/work
Street address
Basij Square
City
Arak
Postal code
3819691187
Phone
+98 86 3278 0660
Fax
Email
mjamilian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehri jamilian
Position
Board of Obstetric
Other areas of specialty/work
Street address
Basij Square
City
Arak
Postal code
3819691187
Phone
+98 86 3278 0660
Fax
Email
mjamilian@arakmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)