The Goal of study is determine the effect of ginger extract on the incidence and severity of nausea and vomiting after cesarean section under spinal anesthesia. In this randomized clinical trial, 92 pregnant women who underwent cesarean section under spinal anesthesia were divided in two groups of control and intervention. Patients should be alert, have class 1 and class 2 of America Society of Anesthesiology (ASA) without any infection or bleeding and ulcers in the area of spinal and without any relative or absolute limitation for spinal anesthesia. The intervention group received 25 drops of ginger extract in 30 cc of water and the control group only received 30 cc of water one hour before surgery. The incidence and severity of nausea and vomiting during the surgery, 2 and 4 hours after the surgery was assessed by self report scale
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042719359N3
Registration date:2016-05-13, 1395/02/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-13, 1395/02/24
Registrant information
Name
Hossein Zeraati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3151 0000
Email address
zeraatih911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, North Khorasan University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ginger extract on the incidence and severity of nausea and vomiting after cesarean section under spinal anesthesia
Public title
The effect of ginger extract on the incidence and severity of nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients should be alert; having class 1 and class 2 of America Society of Anesthesiology (ASA) score; without any infection or bleeding and ulcers in the area of spinal; without any relative or absolute limitation for spinal anesthesia
Exclusion criteria: the patient who referred for cesarean section with a drop in the fetal heart rate, placenta detachment, and placenta previa; the patients who weigh more than 90 kg; diabetics; with underlying gastrointestinal disease; those who had used anti-nausea and anti-vomiting drugs in pre-operative 24 hours before the surgery; those who were not fasting; those with middle ear disease; those who had more than 20% of baseline drop in blood pressure after spinal anesthesia; the patients with gestational hypertension; history of pelvic surgery except caesarean section; history of nausea and vomiting during the past 24 hours
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:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 North Khorasan University of Medical Sciences
Street address
Vice Chancellor for Research of North Khorasan University of Medical Sciences, Bojnurd
City
Bojnurd
Postal code
Approval date
2012-10-27, 1391/08/06
Ethics committee reference number
91/60/1700
Health conditions studied
1
Description of health condition studied
Pregnancy
ICD-10 code
O08
ICD-10 code description
normal pregnancy
Primary outcomes
1
Description
Severity of nausea
Timepoint
During the surgery, 2 hour after the surgery, 4 hour after the surgery
Method of measurement
self-report scale
2
Description
Severity of vomiting
Timepoint
During the surgery, 2 hour after the surgery, 4 hour after the surgery
Method of measurement
self-report scale
Secondary outcomes
1
Description
The incidence of nausea and vomiting
Timepoint
During the surgery, 2 hour after the surgery, 4 hour after the surgery
Method of measurement
Self-report scale
Intervention groups
1
Description
In the intervention group, 25 drops of oral drops containing gingerextract was poured in 30 cc of tap water in a glass and was given to the patients one hour before surgery
Category
Treatment - Drugs
2
Description
The control group received 30 cc of tap water in a glass one hour before surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bentolhoda Hospital
Full name of responsible person
Javad Shahinfar
Street address
ZAyeshgah Ave, Bojnurd, Iran
City
Bojurd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, North Khorasan University of Medical Sciences
Full name of responsible person
Alireza Golshan
Street address
Vice Chancellor for Research, North Khorasan University of Medical Sciences, Bojnurd, Iran
City
Bojnurd
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, North Khorasan 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
North Khorasan University of Medical Sciences
Full name of responsible person
Javad Shahinfar
Position
Instructor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Bojnurd, Iran
City
Bojnurd
Postal code
Phone
+98 58 3229 1910
Fax
Email
dr.jshahinfar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
North Khorasan University of Medical Sciences
Full name of responsible person
Javad Shahinfar
Position
Specialist
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Bojnurd, Iran
City
Bojnurd
Postal code
Phone
+98 58 3229 1910
Fax
Email
dr.jshahinfar@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
North Khorasan University of Medical Sciences
Full name of responsible person
Javad Shahinfar
Position
Instructor
Other areas of specialty/work
Street address
Shahriyar Ave, Bojnurd, Iran
City
Bojnurd
Postal code
Phone
+98 985832211910
Fax
Email
dr.jshahinfar@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)