This clinical trial research has been planned to study intravenous ondansetron effect on the prevention of blood pressure decrease after spinal anesthesia in elective cesarean section patients. 102 healthy pregnant women under spinal anesthesia receive hyperbaric bupivacaine (0.5%) in addition sufentanil (5micro gram) after ringer serum infusion (300cc). Before anesthesia, ondansetron 4mg/IV inject slowly, for case group. For control group placebo is injected. The first consequence is hypotension (SBP <100 mmhg or decrease >20% primary BP). Blood pressure and pulse rate are recorded before and after anesthesia immediately, then every 3min till 10min and every 5min till 30min. If hypotension happens, ephedrine 5_10mg will be injected. Itching and nausea will be recorded every 10min during operation by observation and Question. Scoring: Itching 0: no 1: mild 2: severe (need to treat) Nausea 0: no 1: yes. In both of groups, the effect of ondansetron will be studied in hypotension accuracy, bradycardia, consumed ephedrine amount, itching and nausea.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111138090N1
Registration date:2012-02-28, 1390/12/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-28, 1390/12/09
Registrant information
Name
Bita Malekianzadeh
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1835 0609
Email address
b.malekian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2010-08-24, 1389/06/02
Expected recruitment end date
2011-07-21, 1390/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravenous ondansetron in preventing hypotension in elective cesarean patients under spinal Anesthesia
Public title
Ondansetron effect in cesarean
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: pregnant healthy women who are candidate for elective cesarean section with spinal anesthesia. Exclusion criteria: motion sickness; hypertension; weight greater than 100kg; hepatic disease; migraine; allergy to ondansetron group drugs, using drugs that effect blood pressure or heart rate or serotonin receptor.
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
102
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
Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh Boulevard
City
Hamedan
Postal code
Approval date
2011-02-27, 1389/12/08
Ethics committee reference number
پ/16/70/7/183954
Health conditions studied
1
Description of health condition studied
Spinal anesthesia
ICD-10 code
O29.5
ICD-10 code description
Other complications of spinal and epidural anaesthesia during pregnancy
Primary outcomes
1
Description
Bradycardia
Timepoint
Every 3 min till 10 min after anesthesia then every 5 min
Method of measurement
Heart rate per minute, automatic monitoring
2
Description
Hypotension
Timepoint
Every 3min till 10min after anesthesia, then every 5min till minute 30
Method of measurement
mmHg, automatic
Secondary outcomes
1
Description
Itching
Timepoint
Every 10 minute after anesthesia till minute 30
Method of measurement
Question from patient, scoring: 0 no- 1 mild- 2 severe (need to treat)
2
Description
Nausea and vomiting
Timepoint
Every 10 minute after anesthesia till minute 30
Method of measurement
Question from patient, scoring: 0 no- 1 yes.
3
Description
Mean consumed ephedrine
Timepoint
After anesthesia until end of operation
Method of measurement
Milligram
Intervention groups
1
Description
Case group: 4 mg (2cc) ondansetron IV inject Slowly before spinal anesthesia.
Category
Prevention
2
Description
Control group: 2cc sterile water IV injection before spinal anesthesia.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Bita Malekianzadeh, Anesthesia resident
Street address
Shariati Square
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research vice Chancellorship, Hamedan University of Medical Sciences
Full name of responsible person
Dr. Puran Hajian
Street address
Hamedan University of Medical Science Research vice Chancellorship, Shahid Fahmideh boulevard
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research vice Chancellorship, Hamedan University of Medical Sciences
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
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Bita Malekianzadeh
Position
Anesthesia resident
Other areas of specialty/work
Street address
Shahid Fahmideh boulevard, Hamedan University of Medical Sciences
City
Hamedan
Postal code
Phone
+98 81 1835 0609
Fax
Email
b.malekian@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Bita Malekianzadeh
Position
Anesthesia resident
Other areas of specialty/work
Street address
Shahid Fahmideh boulevard, Hamedan University of Medical Sciences
City
Hamedan
Postal code
Phone
+98 81 1835 0609
Fax
Email
b.malekian@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Bita Malekianzadeh
Position
Anesthesia resident
Other areas of specialty/work
Street address
Shahid Fahmideh boulevard, Hamedan University of Medical Sciences
City
Hamedan
Postal code
Phone
+98 81 1835 0609
Fax
Email
b.malekian@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)