Study of the effectiveness of ondansetron on the prevention of hypotension after spinal anesthesia
Design
This is a open label clinical trial. All pregnant women who are candidates for the cesarean delivery and spinal anesthesia referreing to Imam Reza hospital in Kermanshah city will be enrolled in the study.106 eligible patients will be selected conveniently and randomly will be assigned to intervention and control groups.
Settings and conduct
This study which will be conducted in Imam Reza hospital of Kermanshah city is open label. At the beginning of the study, some symptoms, such as blood pressure, nausea, headache, and chills, will be recorded on a checklist. After the end of the study, the symptoms will be re-evaluated and two groups will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women aged 18 -37 years;
Female candidates for cesarean delivery and spinal anesthesia
Exclusion criteria: Neurological disorders; Injection site infection; Liver Disease and BMI> 30
Intervention groups
The intervention group will receive 7 ml/kg of ondansetron intravenously before the start of spinal.
The control group will receive 7 ml/kg of normal saline intravenously before the start of spinal.
Main outcome variables
blood pressure; nausea and vomiting; Headache; Chill
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N99
Registration date:2018-08-18, 1397/05/27
Registration timing:registered_while_recruiting
Last update:2018-08-18, 1397/05/27
Update count:0
Registration date
2018-08-18, 1397/05/27
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-16, 1397/05/25
Expected recruitment end date
2018-10-17, 1397/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
study the effectiveness of ondansetron on the prevention of hypotension after spinal anesthesia
Public title
study of the effectiveness of ondansetron on the prevention of hypotension after spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women aged between 18 -37 years
Female candidates for cesarean delivery and spinal anesthesia
Exclusion criteria:
Neurological disorders
Injection site infection
Liver Disease and BMI> 30
Age
From 18 years old to 37 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
Individually randomization by random number table via code receipt
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 Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2017-12-13, 1396/09/22
Ethics committee reference number
ir.kums.rec.1396.507
Health conditions studied
1
Description of health condition studied
Spinal anesthesia
ICD-10 code
O29.5
ICD-10 code description
Other complications of spinal and epidural anesthesia during pregnancy
Primary outcomes
1
Description
blood pressure
Timepoint
Immediately after Spinal, every 3 minutes to 30 minutes
Method of measurement
Using the barometer device
2
Description
Nausea and vomiting
Timepoint
The beginning and the end of the study
Method of measurement
Asking of patient
3
Description
Headache
Timepoint
The beginning and the end of the study
Method of measurement
Ask the patient
4
Description
Chill
Timepoint
The beginning and the end of the study
Method of measurement
Asking of patient
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive 7 ml/kg of ondansetron intravenously before the start of spinal.
Category
Treatment - Drugs
2
Description
The control group will receive 7 ml/kg of normal saline intravenously before the start of spinal.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Mahin Molaei
Street address
Parastar Blvd, Emam Reza Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6309
Email
arshiyamolaie58@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mahin Molaei
Position
Resident of Anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Parastar Blvd, Emam Reza Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6309
Email
arshiyamolaie58@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Parisa Golfam
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Parastar Blvd, Emam Reza Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6309
Email
pgolfam@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mahin Molaei
Position
Resident of Anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Parastar Blvd, Emam Reza Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6309
Email
arshiyamolaie58@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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
4 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail