Evaluation of Efficacy of intravenous Atropine in prevention of post spinal hypotension and bradycardia in cesarean section.
Design
The aim of this study was to evaluate the effect of venous atropine on the prevention of hypotension and bradycardia following spinal anesthesia in cesarean section.In this double blind study, 88 patients aged 18 to 46 years with cesarean delivery at Fatemieh Hospital of Hamadan will be treated in one of two groups after receiving informed consent. In one group, 0.5 mg intravenous atropine was administered and in the other group 1 ml normal saline was prepared in the same syringes prepared by the anesthetist nurse according to the predetermined list and immediately injected intraperitoneally after spinal anesthesia. Patients who declare that they are not collaborating or have sensitivity to medications used. will be excluded.
Settings and conduct
Fatemieh Hospital of Hamadan
Participants/Inclusion and exclusion criteria
Satisfaction to participate in the project; Pregnant women aged 18 to 46; Pregnant women who underwent cesarean section under spinal anesthesia
Intervention groups
In one group, 0.5 mg intravenous atropine was administered and in the other group 1 ml normal saline was prepared in the same syringes prepared by the anesthetist nurse according to the predetermined list and immediately injected intraperitoneally after spinal anesthesia.
Main outcome variables
Hypotension and bradycardia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120915010841N18
Registration date:2019-05-17, 1398/02/27
Registration timing:registered_while_recruiting
Last update:2019-05-17, 1398/02/27
Update count:0
Registration date
2019-05-17, 1398/02/27
Registrant information
Name
Nahid Manuchehrian
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7012
Email address
manouchehrian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-15, 1398/02/25
Expected recruitment end date
2020-05-14, 1399/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Efficacy of intravenous Atropine in prevention of post spinal hypotension and bradycardia in cesarean section.
Public title
Efficacy of intravenous Atropine in prevention of post spinal hypotension and bradycardia in cesarean section.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the project
Pregnant women aged 18 to 46
Pregnant women who underwent cesarean section under spinal anesthesia
Exclusion criteria:
sensitivity to medications used
Patients who have failed spinal anesthesia and undergo general anesthesia
Lung disease, heart disease, asthma, fever, hypertension, preeclampsia and eclampsia, cardiac arrhythmia
Multiple pregnancies
HR resting more than 100 in minutes,
Beta-blocker intake
Age
From 18 years old to 40 years old
Gender
Female
Phase
1-2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
In this study , a randomized block design with four replications is used. we provide four paper sheets . We write two letters A and on two other sheets of letter B. We mix the papers together and put them in the drawer of the table.With each of the qualified patients, one of the papers is taken out randomly and will be assigned to one of the two Atropine 0.5 mg or 1 ml of normal saline groups, depending on whether the drawn sheet is either A or B. After the random drawn out of four sheets, all the papers will be returned to the drawer and again the above procedure will continue for the next four patients until it reaches the sample volume.
Blinding (investigator's opinion)
Double blinded
Blinding description
In both groups A and B, medications will be prescribed two minutes before the extubation of the chip. In order to prevent the medication being detectable for patients and investigators, they are prepared and injected into syringes of the same size and shape and on the adhesives A and B by the anesthetist. Since drugs are prescribed and prescribed by an anesthetist, the clinician will not be aware of the type of prescribed medication that will measure and record the outcome of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan university of Medical Science
Street address
Fahmide Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2019-03-09, 1397/12/18
Ethics committee reference number
IR.UMSHA.REC.1397.974
Health conditions studied
1
Description of health condition studied
Spinal anesthesia in cesarean section
ICD-10 code
Z38.01
ICD-10 code description
Single liveborn infant, delivered by cesarean
Primary outcomes
1
Description
hypotension
Timepoint
Every two minutes to 10 minutes, then every 5 minutes to 15 minutes, then every 10 minutes until the end of the surgery
Method of measurement
Non-invasive blood pressure
2
Description
bradycardia
Timepoint
Every two minutes to 10 minutes, then every 5 minutes to 15 minutes, then every 10 minutes until the end of the surgery
Method of measurement
Pulse Oximetry
Secondary outcomes
1
Description
Nausea & vomiting
Timepoint
after delivery
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: 0.5 mg of atropine is injected intravenously after spinal anesthesia
Category
Treatment - Drugs
2
Description
Control group: 1 ml of normal saline is injected intravenously immediately after spinal anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Nahid Manouchehrian, Anesthesiologist, Assistant Professor of Hamadan University Of Medical Sciences
Street address
Fatemieh Hospital, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
hp.fatemieh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Mahdie Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Email
vc_research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemieh Hospital, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
manuchehriann@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate Professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
manuchehriann@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate Professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
manuchehriann@gmail.com
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