Comparison of the Effect of Intrathecal Bupivacaine with Intrathecal Ropivacaine on Hemodynamic of Patients under Elective Caesarean Section
Design
This Study will be done as a Randomized Double-Blind Clinical Trial with 2 parallel groups. 72 Pregnant women with simple randomization method divided into 2 groups: We provide 36 Blue cards (for B group) & 36 Red cards (for R group), place each card in pocket, close pockets & leave them in a Package, Disarrange pockets, then take a pocket randomly without replacing & register subsequence of cards from 1 to 72 & patients will take drugs upon performed subsequence respectively
Settings and conduct
After the grace of ethics committee of Ardabil University, this study will be done in Alavi hospital. We explain the Procedure for patients & obtain satisfaction. Blinds of study are patients & Evaluator. After intravenously hydratation & cardiopulmonary monitoring, Spinal Anesthesia under aseptic condition will be performed. Hemodynamic parameters & side effect of drugs will be recorded & Statistical comparison will be done
Participants/Inclusion and exclusion criteria
-ٍEntrance Criteria: Term Pregnant Women; 18-40 y/o; Physical health class (ASA score): 1-2; Candidated for Caesarean section
-Non Entrance Criteria: Dissatisfaction of Patient for Spinal Anesthesia; Presence of Contraindication for Regional Anesthesia; Pre-term or Post-term Pregnancy; Age<18 or Age>40 y/o; ASA score>2; Urgency Surgery
Intervention groups
Group B: Amp. Bupivacaine 0.5%, 12mg, Single dose, Intrathecally
Group R: Amp. Ropivacaine 0.5%, 18mg, Single dose, Intrathecally
Main outcome variables
Age; Drug group; ASA score; Heart rate; systolic blood pressure; Mean arterial pressure; Decrease of blood pressure; Bradycardia; Nausea or vomiting; Anesthesia level>T4; Time of Decreasing of anesthesia level; Surgeon`s Satisfaction rate about quality of relaxation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190506043495N1
Registration date:2019-05-18, 1398/02/28
Registration timing:prospective
Last update:2019-05-18, 1398/02/28
Update count:0
Registration date
2019-05-18, 1398/02/28
Registrant information
Name
Elham Habibzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3372 6162
Email address
e.habibzadeh@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intrathecal Bupivacaine with intrathecal Ropivacaine on Hemodynamic of patients under Elective Caesarean Section
Public title
Spinal Anaesthesia with Bupivacaine versus Ropivacaine in Caesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Term Pregnant women
18 - 40 Y/O
Physical health class (ASA score): 1-2
Candidated for Caesarean section
Exclusion criteria:
Dissatisfaction of Patient for Spinal Anaesthesia
Presence of Contraindication for Regional Anaesthesia
Pre-term or post-term pregnancy
Age<18 y/o or Age>40 y/o
Physical health class (ASA score) > 2
Urgency surgery
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be done: we provide 36 Blue cards (for Bupivacaine group) and 36 Red cards (for Ropivacaine group), Place each card in pocket, Close pockets and leave them in package, Disarrange pockets, then take a pocket randomly without replacing and register subsequence of cards from 1 to 72 and patients will take drugs upon performed subsequence respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are first blind group without aware from type of given drug. Evaluator of outcomes is second blind that will not presence on anaesthesia time.
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
Ardabil Complex University, Daneshgah st.
City
Ardabil
Province
Ardabil
Postal code
5618985991
Approval date
2019-05-06, 1398/02/16
Ethics committee reference number
IR.ARUMS.REC.1398.042
Health conditions studied
1
Description of health condition studied
Spinal Anaesthesia in Caesarean section
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Heart rate
Timepoint
Before Spinal Anaesthesia and every 2 minutes interval after Spinal Anaesthesia
Method of measurement
Heart monitoring device
Secondary outcomes
1
Description
Systolic blood pressure
Timepoint
Before Spinal Anaesthesia and every 2 minutes interval after Spinal Anaesthesia
Method of measurement
Non invasive automated blood pressure device
Intervention groups
1
Description
Intervention group: Amp. Bupivacaine 0.5% 12.5 mg, Single dose, Intrathecally
Category
Treatment - Other
2
Description
Intervention group: Amp. Ropivacaine 0.5%, 17.5 mg, Single dose, Intrathecally
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alavi hospital
Full name of responsible person
Soheila Mousavi
Street address
alavi hospital, Shahid Maadi Ave.
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Fax
+98 45 3323 7821
Email
alavi@arums.ac.ir
Web page address
http://www.arums.ac.ir/alavi/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Godrat Akhavan Akbari
Street address
Daneshgah st., Ardabil Complex University
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3352 2247
Fax
+98 45 3352 2196
Email
info@arums.ac.ir
Web page address
http://www.arums.ac.ir/en
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
Dr. Ahmad ghazi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Alavi Hospital, Shahid Maadi Ave.
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Fax
+98 45 3323 7821
Email
alavi@arums.ac.ir
Web page address
http://arums.ac.ir/alavi/fa
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Ahmad Ghazi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Alavi Hospital, Shahid Maadi Ave.
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Fax
+98 45 3323 7821
Email
alavi@arums.ac.ir
Web page address
http://www.arums.ac.ir/alavi/fa
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Ahmad Ghazi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Alavi Hospital, Shahid Maadi Ave.
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Fax
+98 45 3323 7821
Email
alavi@arums.ac.ir
Web page address
http://www.arums.ac.ir/alavi/fa
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available