Objective: Comparing the Effect of Intravenous Aminophylline and Ondansetron on Incidence of Post-Dural Puncture Headache in Cesarean Section Surgeries
Study Design: This study is a double blind clinical trial.
Inclusion criteria: women undergoing elective cesarean section under spinal anesthesia ASA class II- I.
Exclusion criteria: pregnant women; heart disease; chronic liver and kidney failure; migraine headaches and stress; chronic hypertension; gestational hypertension; pre-eclampsia; seizures; psychiatric problems; allergy to ondansetron; aminophylline and theophylline; history of drug addiction; failed to spinal anesthesia or more than once spinal anesthesia attempts.
300 pregnant women were divided into three groups of 100, for each group a 5 cc syringe containing normal saline prepared and labeled A ', B' and C 'to make the study double-blind.
Patients in group (A) (n=100) received 1 mg/kg in 5 cc normal saline Aminophylline after clamping the umbilical cord and A’ syringe before performing spinal. Patients in group (B) (n=100) received 0.15 mg/kg in 5 cc normal saline Ondansetron before performing spinal and B’ syringe after clamping the umbilical cord.In the control group(C) (n=100) patients received C, C’ syringe 5 cc normal saline after clamping the umbilical and before performing spinal as placebo.
Primary and secondary outcomes of the study: headache and severity of the headache, incidence of nausea and vomiting every 72, 48, 24 hours in 3 days will be checked and recorded, aminophylline effects on blood pressure and heart rate were also recorded.
After clamping the umbilical cord oxytocin is given routinely and after ensuring that blood pressure and heart rate are stable medication is injected, patients were monitored every 15 minutes to the end of the surgery and then in then recovery room, blood pressure and heart rate were also recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016110519470N50
Registration date:2017-04-04, 1396/01/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-04, 1396/01/15
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
Expected recruitment start date
2017-03-10, 1395/12/20
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effect of Intravenous Aminophylline and Ondansetron on Incidence of Post-Dural Puncture Headache in Cesarean Section Surgeries
Public title
Comparing the Effect of Intravenous Aminophylline and Ondansetron on Incidence of Post-Dural Puncture Headache in Cesarean Section Surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: women undergoing elective cesarean section under spinal anesthesia ASA class II- I.
Exclusion criteria: pregnant women; heart disease; chronic liver and kidney failure; migraine headaches and stress; chronic hypertension; gestational hypertension; pre-eclampsia; seizures; psychiatric problems; allergy to ondansetron; aminophylline and theophylline; history of drug addiction; failed to spinal anesthesia or more than once spinal anesthesia attempts.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
N/A
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
Ethics Committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Approval date
2016-11-02, 1395/08/12
Ethics committee reference number
IR.SUMS.MED.REC.1395.41
Health conditions studied
1
Description of health condition studied
caesarean section
ICD-10 code
082.0
ICD-10 code description
Delivery by elective caesarean sectio
Primary outcomes
1
Description
headache
Timepoint
every 72, 48, 24 hours in 3 days after surgery
Method of measurement
Numerical rating scale (NRS)
2
Description
Nausea and vomiting
Timepoint
every 72, 48, 24 hours in 3 days after surgery
Method of measurement
Observasion
Secondary outcomes
empty
Intervention groups
1
Description
Patients in group (A) (n=100) received 1 mg/kg in 5 cc normal saline Aminophylline after clamping the umbilical cord and A’ syringe before performing spinal.
Category
Treatment - Drugs
2
Description
Patients in group (B) (n=100) received 0.15 mg/kg in 5 cc normal saline Ondansetron before performing spinal and B’ syringe after clamping the umbilical cord.
Category
Treatment - Drugs
3
Description
In the control group(C) (n=100) patients received C, C’ syringe 5 cc normal saline after clamping the umbilical and before performing spinal as placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Sanaz Bayani
Street address
Hafez Hospital, Chamran Boulevard
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
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, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sanaz Bayani
Position
anesthesiology resident/physician
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
00
Fax
Email
sanaz.bayani@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz Universiy of Medical Sciences
Full name of responsible person
Laleh Dehghanpishe
Position
Anesthesiologist
Other areas of specialty/work
Street address
Namazi square, Namazi Hospital
City
Shiraz
Postal code
Phone
00
Fax
Email
lalehdehghan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
MS in english teaching ,BS in anesthesia/English Consultant
Other areas of specialty/work
Street address
5th floor, Mohammad Rasul Allah Research Tower, Khalili Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)