Comparison of the effect of spinal anesthesia with ropivacaine and marcaine in cesarean section of preeclamptic patients
Design
Clinical trial with two parallel, double-blind, randomized groups on 90 patients. Lottery was used for randomization.
Settings and conduct
This study will be performed in Shahid Bahonar Hospital in Kerman. Colleagues who measure hemodynamic and pain indices in the operating room and ward, as well as a statistical analyst, will be unaware of the grouping.
Participants/Inclusion and exclusion criteria
Pregnant women with preeclampsia are candidates for cesarean section
Intervention groups
Intervention 1: Spinal anesthesia with ropivacaine
Intervention 2: Spinal anesthesia with marcain
Main outcome variables
The required dose of ephedrine; Duration of movement block; State of painlessness; blood pressure; Heart rate; Duration of onset of motor block
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150317021497N6
Registration date:2021-05-09, 1400/02/19
Registration timing:registered_while_recruiting
Last update:2021-05-09, 1400/02/19
Update count:0
Registration date
2021-05-09, 1400/02/19
Registrant information
Name
Mohammadreza Mokhtaree
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34260081
Email address
mrmokhtaree@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-03, 1400/02/13
Expected recruitment end date
2021-07-21, 1400/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Spinal Anesthesia with Ropivacaine and Marcain on Cesarean Section in Preeclampsia Patients
Public title
Comparison of Ropivacaine and Marcain on Cesarean Section in Preeclampsia Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with preeclampsia
Satisfaction with spinal anesthesia
Absence of thrombocytopenia (PLT <70000) with coagulation disorder
Absence of spinal infection
Exclusion criteria:
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Random block assignment to two groups
Blinding (investigator's opinion)
Double blinded
Blinding description
Colleagues who measured hemodynamic and pain indices in the operating room and ward, as well as a statistical analyst, were unaware of the grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Qarni St., Shahid Bahonar Hospital
City
Kerman
Province
Kerman
Postal code
7613747181
Approval date
2019-12-05, 1398/09/14
Ethics committee reference number
IR.KMU.AH.REC.1398.151
Health conditions studied
1
Description of health condition studied
Hemodynamic indices, duration of motor block onset, duration of motor block, required dose of ephedrine
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hemodynamic indices, duration of motor block onset, duration of motor block, required dose of ephedrine
Timepoint
Before anesthesia, after anesthesia in 2, 4, 6, 8, 10, 15, 20, 25, 30, 35 minutes
Method of measurement
Checklist, monitoring device, mercury barometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Spinal anesthesia with ropivacaine
Category
Treatment - Drugs
2
Description
Intervention group: Spinal anesthesia with marcainee
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar Hospital
Full name of responsible person
Abbas Pardakhty
Street address
Somayeh intersection (Tahmasb Abad) at the beginning of Ibn Sina Street
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3815
Email
abpardakhty@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Somayeh intersection (Tahmasb Abad) at the beginning of Ibn Sina Street
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3815
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Leila Rezaeizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Qarni St., Shahid Bahonar Hospital
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
l.rezaizadeh@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Leila Rezaeizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Qarni St., Shahid Bahonar Hospital
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
l.rezaizadeh@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Leila Rezaeizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Qarni St., Shahid Bahonar Hospital
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
l.rezaizadeh@kmu.ac.ir
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
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
6 months from the end of the study
To whom data/document is available
Only researchers working in academic and scientific institutions
Under which criteria data/document could be used
Information is provided only by letter from the scientific and academic institute.
From where data/document is obtainable
Leila Rezaeizadeh, 09131782131
What processes are involved for a request to access data/document
After submitting the official letter, the permit is issued by the Deputy Minister of Research.