This study is a clinical trial. Sampling is from referred people to Azad university hospitals of Tehran. Objectives of the study include the identification of more effective drugs to control nausea and vomiting during spinal anesthesia for cesarean section; determine the relationship between age and anti-nausea drugs; determine the relationship between body weight and anti-nausea drugs. Samples collect from 144 people and all the pregnant women who were referred to hospitals for cesarean section.Inclusion criteria having no problems during pregnancy including gestational hypertension; placenta abruption; fetal distress.Patients after obtaining written consent were randomly assigned into one of the groups received propofol, metoclopramide, dexamethasone and distilled water are placed in four groups of 36 people,and they will be controlled severity of nausea and vomiting after surgery. The results lead to improved maternal and increase the quality of the newborn in the first minutes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016072729103N1
Registration date:2016-09-18, 1395/06/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-09-18, 1395/06/28
Registrant information
Name
bahareh safarian
Name of organization / entity
azad university
Country
Iran (Islamic Republic of)
Phone
+98 21 8868 5262
Email address
bahar.sa@iau-shahrood.ac.ir
Recruitment status
Recruitment complete
Funding source
Azad university hospitals of Tehran
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of metoclopramide, propofol and dexamethasone in controlling nausea and vomiting during spinal anesthesia for cesarean section
Public title
The effect of metoclopramide, propofol and dexamethasone in controlling nausea and vomitin for cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: lack of hypertension in pregnancy; motion sickness; active bleeding; fetal distress; placental abruption; placenta Peravia; history of the gastrointestinal disease; systolic blood pressure less than 90 or hypotension more than 30% of the initial pressure.There is not any exclusive criteria.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
144
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 shahrood university of medical sciences
Street address
Hafte tir square, Shahrood
City
Shahrood
Postal code
Approval date
2015-12-22, 1394/10/01
Ethics committee reference number
ir.shmu.rec.1394.147
Health conditions studied
1
Description of health condition studied
nausea vomiting
ICD-10 code
R11
ICD-10 code description
nausea and vomiting
2
Description of health condition studied
Vomiting
ICD-10 code
K91.9
ICD-10 code description
Postprocedural disorder of digestive system, unspecified
Primary outcomes
1
Description
nausea
Timepoint
Recovery; first,third, sixth and twelfth hour after surgery and before discharge
Method of measurement
mild modereate sever
2
Description
vomiting
Timepoint
Recovery; first, third, sixth and twelfth hour after surgery and before discharge
Method of measurement
yes or no
Secondary outcomes
empty
Intervention groups
1
Description
Metoclopramide 0.1 mg/kg IV
Category
Treatment - Drugs
2
Description
Dexamethasone 150 ug/kg IV
Category
Treatment - Drugs
3
Description
Propofol 0.1 mg/kg IV
Category
Treatment - Drugs
4
Description
Normal saline 2ml IV
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin hospital
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Bouali hospital
Full name of responsible person
Street address
City
Tehran
3
Recruitment center
Name of recruitment center
Javaheri hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of research and technology at azad university of Tehran
Full name of responsible person
Dr Hasan Ardebili
Street address
Islamic azad university, Khaghani street, Shariati street,, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research and technology at azad university of Tehran
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
Amiralmomenin hospital
Full name of responsible person
Dr Sarabandi
Position
Pediatric doctor
Other areas of specialty/work
Street address
Amiralmomenin hospital, Shirmohamadi street, Nazi abad street, Tehran
City
Tehran
Postal code
Phone
+98 21 5534 6262
Fax
Email
drsarabandi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic azad university of Shahrood
Full name of responsible person
Lila Khojasteh
Position
Anesthesiologist doctor
Other areas of specialty/work
Street address
Khatamalanbia hospital, University boulevard, Shahrood
City
Shahrood
Postal code
Phone
+98 23 3239 0360
Fax
Email
drlilakhojaste@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Azad university of Shahrood
Full name of responsible person
Dr Noori
Position
Anesthesiologist doctor
Other areas of specialty/work
Street address
City
Shahrood
Postal code
Phone
+98 23339661
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)