Comparison of the effect of combination of Metoclopramide and Dexamethasone with Ondrosterone and Midazolam in the prevention of nausea and vomiting during and after cesarean section patients with spinal anesthesia
Determining the effect of metoclopramide combination of dexamethasone with endosterone and midazolam on the prevention of recurrence and exfoliation during and after cesarean section in patients with spinal anesthesia
Design
150 patients with cesarean section will be selected. Clinical trials will be without control groups with parallel groups. Accidentalization and blindness have not been observed in the study. The study will be conducted in phase 3 of the clinical trial.
Settings and conduct
The study will be held at Alavi Hospital in Ardabil. The study will be conducted in phase 3. Blindness has not been observed in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
cesarean section indication
Exclusion criteria:
Having any chronic disease, Drug addiction
Intervention groups
Intervention group1:This group includes 75 pregnant women with cesarean section indications. In this group, metoclopramide ampoules will be injected into patients in 10 mg intravenously and dexamethasone 8 mg intravenously.Intervention group2:This group includes 75 pregnant women with cesarean section indications. To this group, patients will be injected with Andansteron ampoules 4 mg intravenously and Midazolam 10 mg intravenously.
Main outcome variables
Vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190901044658N2
Registration date:2020-06-22, 1399/04/02
Registration timing:registered_while_recruiting
Last update:2020-06-22, 1399/04/02
Update count:0
Registration date
2020-06-22, 1399/04/02
Registrant information
Name
Shahla Farzipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3323 0739
Email address
m.rezayi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of combination of Metoclopramide and Dexamethasone with Ondrosterone and Midazolam in the prevention of nausea and vomiting during and after cesarean section patients with spinal anesthesia
Public title
Comparison of the effect of metoclopramide and dexamethasone with androsterone and midazolam in the prevention of nausea and vomiting during and after cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a cesarean surgery indication
Exclusion criteria:
Having Chronic disease
Drug addiction
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
No. 1, Daneshgah Ave
City
Ardabil
Province
Ardabil
Postal code
5613843793
Approval date
2020-01-18, 1398/10/28
Ethics committee reference number
IR.ARUMS.REC.1398.577
Health conditions studied
1
Description of health condition studied
Caesarean section
ICD-10 code
O80
ICD-10 code description
Encounter for full-term uncomplicated delivery
Primary outcomes
1
Description
Vomiting
Timepoint
Before cesarean section and after cesarean section
Method of measurement
Number of patients vomit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: This group includes 75 pregnant women with cesarean section indications. To this group, metoclopramide ampoules will be injected into patients 10 mg intravenously by Osweh and dexamethasone 8 mg intravenously by Caspian Company under anesthesia.
Category
Treatment - Drugs
2
Description
Intervention group2:This group includes 75 pregnant women with cesarean section indications. To this group, Andansteron ampoules will be injected into patients 4 mg intravenously by Elixir Daru and Midazolam 10 mg intravenously by Abu Reihan Company under anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alavi hospital
Full name of responsible person
Dr Parvin Jabbari
Street address
No. 1, Moallem Ave.
City
Ardabil
Province
Ardabil
Postal code
5613843793
Phone
+98 45 3323 0739
Email
meisamfooladi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Parvaneh Naftchi
Street address
No. 1, Daneshgah Ave
City
Ardabil
Province
Ardabil
Postal code
5613843887
Phone
+98 45 3323 0739
Email
meisamfooladi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Shahla Farzipour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 1, Moallem Ave.
City
Ardabil
Province
Ardabil
Postal code
5613843793
Phone
+98 45 3323 0739
Email
meisamfooladi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Shahla Farzipor
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. , Moallem Ave.
City
Ardabil
Province
Ardabil
Postal code
5613843793
Phone
+98 45 3323 0739
Email
meisamfooladi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Shahla Farzipour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 1, Moallem Ave.
City
Ardabil
Province
Ardabil
Postal code
5613843793
Phone
+98 45 3323 0739
Email
meisamfooladi@GMAIL.COM
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The questionnaires will be made available anonymously and with a file number
When the data will become available and for how long
After completing the study
To whom data/document is available
University professors
Under which criteria data/document could be used
In order to find out how to work in SPSS file, anonymous questionnaires will only be available with file number.
From where data/document is obtainable
Contact Dr. Shahla parzipour
What processes are involved for a request to access data/document
Information is available after contacting Dr. Shahla farzipour and University approval