Survey of effect of intravenous granisetron on attenuation of hemodynamic responses of spinal anesthesia in patients undergoing elective caesarian section
Due to the role of serotonin in onset of symptoms of anesthesia , serotonin blockers like Ondansetron and Granisetron are taken into consideration to reduce this side effects . To data Granisetron effect on reducing hypo tension and bradycardia that caused by spinal block has not been evaluated. In this study we will assess the effect of intravenous Granisetron to reduction of hemodynamic changes due to spinal anesthesia. Sample size is 48 pregnant women. The process will be allocation of the patients to two control and intervention groups and receiving 3 ml normal saline by control group and 3 ml intravenously Gransitron by intervention group. Then systolic and diastolic blood pressure and heart rate will be measured in specific times and finally two groups will be compared. The study will be double blinded (patients and researchers)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201411265140N15
Registration date:2015-04-12, 1394/01/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-12, 1394/01/23
Registrant information
Name
Omid Azimaraghi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2206 6194
Email address
cazimaraghi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tehran University of Medical Science
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of effect of intravenous granisetron on attenuation of hemodynamic responses of spinal anesthesia in patients undergoing elective caesarian section
Public title
Attenuation of anesthesia changes in patients undergoing elective caesarian section
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: All patients who refer to elective cesarean in Shariati hospital; patients with I or II grade of ASA.
Exclusion criteria; patients with Contra indications block subarachnoid; patients with increased sensitivity to Gransytrvn or drugs of local anesthetics; patients with pregnancy induced hypertension ; patients with inadequate cardiovascular, patients who receiving SSRI or drugs for migraine; the presence of any systemic disease in pregnant; cigarette smokers; alcohol users; patients taking any medication other than prenatal supplements contain iron, folic acid and multivitamins.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Poursina Ave, North Karghar, Enghelab Sq, Tehran
City
Tehran
Postal code
Approval date
2014-12-21, 1393/09/30
Ethics committee reference number
2189/130/د/92
Health conditions studied
1
Description of health condition studied
Cesarean
ICD-10 code
O29.4
ICD-10 code description
Spinal and epidural anaesthesia-induced headache during pregnancy
Primary outcomes
1
Description
Heartbeat
Timepoint
In the 2-minute intervals up to 20 minutes and then in 5 -minute intervals until the end of surgery
Method of measurement
Existing equipment in hospital
2
Description
Systolic and diastolic blood pressure
Timepoint
In the 2-minute intervals up to 20 minutes and then in 5 -minute intervals until the end of surgery
Method of measurement
Existing equipment in hospital
3
Description
SPO2
Timepoint
In the 2-minute intervals up to 20 minutes and then in 5 -minute intervals until the end of surgery
Method of measurement
Existing equipment in hospital
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:3 ml Granisetron will prescribe intravenously 5 min before spinal block.
Category
Placebo
2
Description
Control group: 3 ml of normal saline will prescribe 5 minutes before spinal block.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tehran University of Medical scinces
Full name of responsible person
Masoud Younesian
Street address
Tehran University of Medical Sciences, Poursina Ave, Enghelab Sq, North Karghar
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Tehran University of Medical scinces
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
Shariati hospital
Full name of responsible person
Somayeh Mehrpou
Position
Assistant Anesthesiology student
Other areas of specialty/work
Street address
Shariati hospital,Jalal Al Ahmad Intersection, North Kargar Av, Tehran
City
Tehran
Postal code
Phone
+98 912 210 2284
Fax
Email
somayeh.mehrpour@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shariati hospital
Full name of responsible person
Somayeh Mehrpou
Position
Assistant Anesthesiology student
Other areas of specialty/work
Street address
Shariati hospital,Jalal Al Ahmad Intersection, North Kargar Av, Tehran
City
Tehran
Postal code
Phone
+98 912 210 2284
Fax
Email
somayeh.mehrpour@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shariati hospital
Full name of responsible person
Somayeh mehrpour
Position
Assistant Anesthesiology student
Other areas of specialty/work
Street address
Shariati hospital,Jalal Al Ahmad Intersection, North Kargar Av, Tehran
City
Tehran
Postal code
Phone
+98 912 210 2284
Fax
Email
somayeh.mehrpour@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)