The aim of this study was to evaluate the effects of gabapentin in preventing nausea and vomiting after spinal anesthesia in cesarean delivery. This study as a double-blind clinical trial was done on 200 candidates of cesarean with a random distribution for a period of four months.Inclusion criteria was pregnant women candidates for elective Caesarean section & Exclusion criteria were patients who history of corticosteroid medications before surgery Antinausea; history of narcotics. Patients were divided into two groups. Treatment group received 600 mg capsule (gabapentin) 1 hour before surgery and the control group received placebo. Primary outcome were nausea and vomiting.Nausea, according to fourth scale of (high, medium, low or not) and vomiting on a binary scale( yes and no), every hour to 4 hours after the withdrawal of mother from the recovery section.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013031211581N3
Registration date:2014-09-27, 1393/07/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-27, 1393/07/05
Registrant information
Name
Rahmatallah Jadidi
Name of organization / entity
Arak University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3641
Email address
dr.jadidi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Voice Chancellor Education & Research of Arak University of Medical Science
Expected recruitment start date
2012-12-04, 1391/09/14
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Gabapentin effect on preventing of nausea and vomiting in cesarean
Public title
The effect of Gabapentin on preventing the nausea and vomiting of patients after spinal anesthesia in the surgery of cesarean
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women candidates for elective Caesarean section
Exclusion criteria:patients who undergo surgery have complication: contraindication to gabapentin; history of corticosteroid medications before surgery Antinausea; history of narcotics before surgery
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
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 Arak University of Medical Science
Street address
Arak University of Medical Science, Sardasht, Arak
City
Arak
Postal code
Approval date
2012-12-03, 1391/09/13
Ethics committee reference number
91-138-7
Health conditions studied
1
Description of health condition studied
Nausea and Vomiting after Spinal Anesthesia in Cesarean
ICD-10 code
O74
ICD-10 code description
Complications of anaesthesia during labour and delivery
Primary outcomes
1
Description
Nausea and Vomiting
Timepoint
every hour until 4 hours
Method of measurement
Nausea, according to fourth scale (high, medium, low or not) and vomiting on a binary scale (yes and no), frequency of vomiting
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:giving 600 mg Gabapentin capsules with 150 cc of water 1 hour before surgery.
Category
Prevention
2
Description
Control group: placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Afsaneh Norouzi
Street address
Anesthesia Ward, Taleghani Hospital, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Science
Full name of responsible person
Dr. Saeid Changizi Ashtiani, Teaching and Research Assistant, Arak University of Medical Science
Street address
Arak University of Medical Science, Sardasht, Arak
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 Science
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 Science
Full name of responsible person
Fereshteh Memari
Position
Expert of Anesthesiology
Other areas of specialty/work
Street address
Operating Room, Amirkabir Hospita, Arak
City
Arak
Postal code
Phone
+98 86 3656 9688
Fax
Email
angelanesthesia@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Science
Full name of responsible person
Dr.Afsaneh Norouzi
Position
َAnesthesiologist
Other areas of specialty/work
Street address
Operating Room, Amirkabir Hospital, Arak
City
Arak
Postal code
Phone
+98 86 3277 6064
Fax
Email
norouzi43@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Science
Full name of responsible person
Dr.Rahmatollah Jadidi
Position
Assistant Professor
Other areas of specialty/work
Street address
Arak University of Medical Science, Sardasht, Arak