The purpose of the study is Comparison of the prophylactic effect of intravenous Ondansetron and Granisetron on hypotension induced through spinal anesthesia in cesarean delivery. Population studied are pregnant women 18 to 45 years that candidate for elective cesarean delivery and have no contraindication for spinal anesthesia. The subjects were divided into 3 groups. O group 5 minutes before spinal anesthesia received 4 mg Ondansetron, G group received 1mg Granisetron and S group received normal saline. The sample size will be 70 in each group and 210 in total. Study is double-blind. Systolic and diastolic blood pressure and mean arterial pressure and heart rate will be record before spinal anesthesia and every 3 minutes to 20 minutes after its. In the event hypotension (systolic blood pressure less than 90mmHg) or bradycardia (heart rate less than 50) will be treated with Ephedrine and Atropine respectively. Nausea, vomiting and chill complaint will be recorded and treated with Metoclopramide and Petedin
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061334519N1
Registration date:2017-08-14, 1396/05/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-14, 1396/05/23
Registrant information
Name
Marzieh Fadaei
Name of organization / entity
Zahedan medical science university
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 0475
Email address
m.fadaei@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research , Zahedan university of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-04-20, 1397/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Prophylactic Effect Of Intravenous Ondansetron And Granisetron on Hypotension Induced Through Spinal Anesthesia in Cesarean Delivery
Public title
Effect of Granisetron & Ondansetron on induced hypotension of spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women aged 18 to 45 with ASA class1,2 for elective cesarean section under spinal anesthesial.
Exclusion criteria: coagulopathy; hemodynamic impaired; history of allergy to anesthesia or medication drugs are studied; taking SSRI anti-seizure & anti migraine; patients suffering from hypertensive disorder; any contraindication to spinal anesthesia; spinal anesthesia failure
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Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
210
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Sampling will be random selection based on the gradual reference of eligible samples. The assignment methode will be based on permuted block randomization. Study is double_blind, patients and those who measure the study variables are not aware of the distribution of the groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Zahedan University Of Medical Sciences
Street address
Office complex pardis of Zahedan University Of Medical Sciences university, Square of Dr Hesabi
City
Zahedan
Postal code
9816743463
Approval date
2017-05-28, 1396/03/07
Ethics committee reference number
IR.ZAUMS.REC.1396.36
Health conditions studied
1
Description of health condition studied
cesarian
ICD-10 code
080-082
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
Hemodynamic condition
Timepoint
befor of intervension then every 3minutes to 20 minutes
Method of measurement
by monitor device
Secondary outcomes
1
Description
hypotension
Timepoint
befor intervention then every 3minute until 20 minutes
Method of measurement
by the monitor
2
Description
bradicardia
Timepoint
befor intervention then every 3minute until 20 minutes
Method of measurement
by the monitor
3
Description
nausea
Timepoint
when event
Method of measurement
patient complain
4
Description
vomiting
Timepoint
when event
Method of measurement
patient complain
5
Description
chill
Timepoint
when event
Method of measurement
patient complain
Intervention groups
1
Description
O intervention group: 4mg Ondansetron that diluted with 10cc saline normal is injecting intravenously 5 minutes before spinal anesthesia
Category
Treatment - Drugs
2
Description
G group intervention: 1mg Granisetron that diluted with 10cc saline normal is injecting intravenously 5minutes befor spinal anesthesia
Category
Treatment - Drugs
3
Description
control group: 10cc saline normal is injecting 5minutes befor spinal anesthesia
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ebne Abitaleb Hospital
Full name of responsible person
Dr Asadollah Shakeri
Street address
Ali ebne abitaleb hospitsl.Khalije Fars Blvd
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Zahedan Medical Science University
Full name of responsible person
Dr Nurmohammad Bakhshani
Street address
. research deputy of Zahedan medical science university,DrHesabi squar
City
Zahedan
Grant name
-0
Grant code / Reference number
-0
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Zahedan Medical Science University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan Medical Science University
Full name of responsible person
Dr Marzieh Fadaei
Position
Anesthesia assistant
Other areas of specialty/work
Street address
Anesthesia department of Ali ebne Abitaleb hospital, Khalijefars Blvd
City
Zahedan
Postal code
9816743111
Phone
+98 54 3329 0475
Fax
+98 54 3329 5596
Email
m_fadaei1979@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan medical science university
Full name of responsible person
Dr Asadollah Shakeri
Position
Anesthesiologist. Pain interventional fluship
Other areas of specialty/work
Street address
Anesthesia department of Aliebne Abitaleb hospital, Khalijefarse Blvd
City
Zahedan
Postal code
9816743111
Phone
+98 54 3329 5584
Fax
+98 54 3329 5593
Email
Ashakeri123@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan medical science university
Full name of responsible person
Dr Marzieh Fadaei
Position
Anesthesia assistant
Other areas of specialty/work
Street address
Anestbesia department of Aliebne Abitaleb hospital, Khalijefars Blvd
City
Zahedan
Postal code
9816743111
Phone
+98 54 3329 0475
Fax
+98 54 3329 5593
Email
m_fadaei1979@yahoo.comm.fadaei1979@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)