The Evaluation of the effect of preoperative(spinal Anesthesia) Atropine administration on maternal hemodynamics and PH of neonatal umbilical cord blood in parturients undergoing cesarean section under spinal anesthesia
The Evaluation of the effect of preoperative (spinal anesthesia) Atropine administration on maternal hemodynamics and neonatal umbilical cord blood PH in parturients undergoing cesarean section under spinal anesthesia
Design
This randomized double blinded clinical trial includes 2 case and control groups. Randomization will be performed by using a random number table that divides the patients into two-40 patients group(total 80 patients) and allocates a code to each person and group. This study will be performed in phase 4.
Settings and conduct
This study will be conducted in Imam Khomeini Hospital Complex. After randomization, using convenient and consequent sampling, the patients that are candidates for the elective cesarean section will receive a single dose of atropine(10 microgram/kg) or placebo, and they will undergo spinal anesthesia. Afterward, maternal hemodynamic parameters including heart rate, blood pressure and Ph of the neonatal umbilical cord blood sample would be tested and registered.
Participants/Inclusion and exclusion criteria
All parturients who are between 18 to 45 years old and are candidates for performing elective cesarian section under spinal anesthesia.
Intervention groups
All healthy parturients who are between 18 to 45 years old and are candidates for performing elective cesarean section under spinal anesthesia will be randomly categorized into two groups including intervention and placebo group using random number table. In the first group we will administer Atropine at maximum dose of 0.6 mg and normal saline will be administered to the second group as placebo at equivalent volume
Main outcome variables
maternal hemodynamic parameters; Ph of the neonatal umbilical cord blood sample; the amount of medications used
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160208026447N2
Registration date:2021-04-07, 1400/01/18
Registration timing:retrospective
Last update:2021-04-07, 1400/01/18
Update count:0
Registration date
2021-04-07, 1400/01/18
Registrant information
Name
Amirhossein Orandi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2828
Email address
horandi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
2016-03-20, 1395/01/01
Actual recruitment end date
2017-05-21, 1396/02/31
Trial completion date
2017-05-22, 1396/03/01
Scientific title
The Evaluation of the effect of preoperative(spinal Anesthesia) Atropine administration on maternal hemodynamics and PH of neonatal umbilical cord blood in parturients undergoing cesarean section under spinal anesthesia
Public title
The Evaluation of the effect of Atropine administration on parturients' hemodynamics undergoing cesarean section under spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant females 18 to 45 years old undergoing cesarean section under spinal anesthesia
Pregnant females without cardiac or other systemic diseases
Pregnant females who have filled written informed consent to perform spinal anesthesia
Exclusion criteria:
disagreement in participating in study
any history of cardiac diseases
Age
From 18 years old to 45 years old
Gender
Female
Phase
4
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this clinical trial, two groups, including intervention group (I) and placebo (P), were randomly assigned based on a table of even and odd random numbers (including a chain of 80 numbers) designed by a statistical consultant. At the time of the patient's entry into the operating room, based on the sequence of the even and odd random number chain, if it was an even number, the envelope containing a prepared atropine syringe delivered to the injector, and if it was an odd number, the envelope containing prepared normal saline delivered to the injector.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs and placebo are prepared in similar envelopes. Each drug envelope is given a code. Each patient is given a code as well. Patients receive an envelope in order of arrival. This envelope is returned on the day of surgery by an unrelated person. Only the analyzer knows which drug and patient belong to which group. Researchers and patients are unaware of the type of code and the content of the codes
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences- Imam Khomeini Hospital Complex
Hemodynamic changes after spinal anesthesia in elective cesarean section
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
maternal hemodynamic parameters
Timepoint
After administering Atropine as premedication or normal saline as a placebo the maternal vital signs would be checked and recorded, thereafter spinal anesthesia will be provided, and after repositioning to the supine position the vital signs would be checked instantly and would be repeatedly checked every 3 minutes. After delivery, the Ph of neonatal umbilical cord blood sample would be checked instantly and will be recorded.
Method of measurement
Vital signs monitoring system
2
Description
Ph of umbilical cord blood sample
Timepoint
After administering Atropine as premedication or normal saline as a placebo the maternal vital signs would be checked and recorded, thereafter spinal anesthesia will be provided, and after repositioning to the supine position the vital signs would be checked instantly and would be repeatedly checked every 3 minutes. After delivery, the Ph of neonatal umbilical cord blood sample would be checked instantly and will be recorded.
Method of measurement
Using Blood Gas Analysis
Secondary outcomes
1
Description
The number of drugs used during surgery
Timepoint
At the end of surgery
Method of measurement
the number of drugs used at the end of procedure
Intervention groups
1
Description
Intervention group: Administration of 10 microgram/kg atropine intravenously prior to performing spinal anesthesia.
Category
Prevention
2
Description
Control group: administration of normal saline in equivalent volume of drug used in case group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Dr.Amirhossein Orandi
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2828
Email
horandi@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amirhossein Orandi
Street address
Keshavarz Blvd-Imam Khomeini hospital Complex- department of Anesthesiology
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2828
Email
horandi@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Amirhossein Orandi
Position
Assistant professor of department of anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Keshavarz Blvd- Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2828
Email
horandi@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Amirhossein Orandi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini hospital, end of Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2828
Fax
Email
horandi@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Amirhossein Orandi
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini hospital, end of Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2828
Fax
Email
horandi@sina.tums.ac.ir
Web page address
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results of the study will be published without any name.
When the data will become available and for how long
1year
To whom data/document is available
The researcher and his supervisor ( professor)
Under which criteria data/document could be used
In order to publish in medical journals, without any name of participants.
From where data/document is obtainable
researcher and supervisor( professor)
What processes are involved for a request to access data/document
sending an appropriate written request to the supervisor