Comparison of the Effects of Ropivacine 0.2% and Bupivacaine 0.5% on Hemodynamic Heart Consequences in Cesarean Section Using Epidural Anesthesia in Besat Hospital, Sanandaj, Iran
Comparison of the Effects of Ropivacine 0.2% and Bupivacaine 0.5% on Hemodynamic Heart Consequences in Cesarean Section Using Epidural Anesthesia
Design
Two intervention groups of 61 people, parallel, double-blind, randomized
Settings and conduct
Pregnant women who are candidates for elective cesarean section are randomly divided into two groups of 61 patients. Medication stickers are separated by a statistical adviser and they will be coded. Then injected into patients.Participants in the study and researcher and information collector and clinical observer are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria include pregnant women aged 20 to 35 years, an indication of elective cesarean section with epidural anesthesia, informed consent of patients and the possibility of epidural anesthesia. Exclusion criteria include underlying illnesses such as blood pressure, diabetes, heart disease, coagulation disorder; pregnancy complications such as placental abruption, preeclampsia, fetal distress, IUGR, Allergy to local anesthetics, Alcoholism and drug Addiction and Local infection.
Intervention groups
The first intervention group is a group of patients who Will be anesthetized with 20 ml of rupivacaine 0.2% with epidural anesthesia.
The second intervention group is a group of patients who Will be anesthetized with 20 ml of bupivacaine 0.5% with epidural anesthesia.
Main outcome variables
The incidence of hypotension (less than 20% of the baseline); the incidence of bradycardia (less than 60)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181022041413N1
Registration date:2019-01-23, 1397/11/03
Registration timing:retrospective
Last update:2019-01-23, 1397/11/03
Update count:0
Registration date
2019-01-23, 1397/11/03
Registrant information
Name
Behzad َAhsan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3323 1805
Email address
sinasoltanian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-17, 1397/07/25
Expected recruitment end date
2018-12-15, 1397/09/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Ropivacine 0.2% and Bupivacaine 0.5% on Hemodynamic Heart Consequences in Cesarean Section Using Epidural Anesthesia in Besat Hospital, Sanandaj, Iran
Public title
Comparison of the Effects of Ropivacine 0.2% and Bupivacaine 0.5% on Hemodynamic Heart Consequences in Cesarean Section Using Epidural Anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women 20 to 35 years old
Indication for elective cesarean section with epidural anesthesia
Informed consent
Possibility of epidural anesthesia
Exclusion criteria:
Underlying disease like hypertension, diabetes, heart disease, coagulation disorders
Pregnancy complications such as placental abruption, preeclampsia, fetal distress, IUGR
Allergy to local anesthetics
Alcoholism and drug Addiction
Local infection
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
122
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done based on throwing coins. And from the number 1 to 122, the coin is thrown. And based on throwing coins, they are placed in the rupivacaine or bupivacaine group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and blindness is done by a statistic consultant. And the label of the vial of medications is taken. And are numbered from 1 to 122. According to the number of patients entering the study, each number is assigned to one person. Participants in the study and researcher and information collector and clinical observer are blind. And they are not aware of the drug inside the vial.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, Pasdaran Blv
City
Sanandaj
Province
Kurdistan
Postal code
666147 - 13446
Approval date
2018-10-17, 1397/07/25
Ethics committee reference number
IR.MUK.REC.1397.182
Health conditions studied
1
Description of health condition studied
Elective cesarean section
ICD-10 code
ICD-10 code description
Elective cesarean section
Primary outcomes
1
Description
Incidence rate of hypotension during epidural anesthesia: If the blood pressure is less than 20% of the basic rate, defined hypotension
Timepoint
Blood pressure will be measure and record at the time before the anesthesia and do 5 minutes and 10 minutes 15 minutes 20 minutes and 35 minutes and 50 minutes and 65 minutes after anesthesia
Method of measurement
Sphygmomanometer
Secondary outcomes
1
Description
Incidence rate of bradycardia during epidural anesthesia: If the pulse rate is less than 60, defined bradycardia
Timepoint
Pulse rate will be measure and record at the time before the anesthesia and do 5 minutes and 10 minutes 15 minutes 20 minutes and 35 minutes and 50 minutes and 65 minutes after anesthesia
Method of measurement
Cardiac monitoring
Intervention groups
1
Description
Intervention group: The first intervention group: 61 patients receiving 20 ml of rupivacaine 0.2% once for epidural anesthesia.
Category
Treatment - Drugs
2
Description
Control group: Second intervention group: 61 patients receiving 20 ml of bupivacaine 0.5 once once for epidural anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Behzad Ahsan
Street address
Pasdaran Blv, Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
666147 - 13446
Phone
+98 87 3323 1805
Email
sinasoltanian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Ebrahim Ghaderi
Street address
Kurdistan University of Medical Sciences, Pasdaran Blv
City
Sanandaj
Province
Kurdistan
Postal code
13446-666147
Phone
+98 87 3182 7272
Email
ebrahimghaderi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Sina Soltanian
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Kurdistan University of Medical Sciences, Pasdaran Blv