Comparison prophylactic effect of Ondansetron and Dexamethasone in management post- dural puncture headache (PDPH) in women candidated for elective Cesarean
The main objective of this study is comparing the efficacy of ondansetron and dexamethasone in controlling headaches associated with spinal anesthesia in non-emergent candidates for cesarean-section.
Design
120 women candidates for cesarean-section in Taleghani hospital in Arak city will be enrolled in the study and equally be divided to three groups randomly by random number table . This study is clinical trial and double blind.
Settings and conduct
This study is a clinical trial and double blind that will be done in Taleghani hospital in Arak city.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; Elective repeated (second) cesarean section; candidate for cesarean with spinal anesthesia
Exclusion criteria: lack of consent; candidate cesarean with general anesthesia; drug allergy; emergency cesarean section
Intervention groups
120 c-section candidates will be enrolled in the study and equally will be divided to three groups. Study groups 1, 2 and 3 will receive intravenous ondansetron, intravenous dexamethasone, and intravenous distilled water (placebo).
Main outcome variables
Headache intensity at 12, 24, and 48 hours post-operative via the visual analogue scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170802035464N2
Registration date:2018-07-04, 1397/04/13
Registration timing:retrospective
Last update:2018-07-04, 1397/04/13
Update count:0
Registration date
2018-07-04, 1397/04/13
Registrant information
Name
Shakiba Homayooni
Name of organization / entity
Medicine StudentArak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 6055
Email address
homayoni.sh@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor research, Arak University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison prophylactic effect of Ondansetron and Dexamethasone in management post- dural puncture headache (PDPH) in women candidated for elective Cesarean
Public title
A clinical trial comparing the preventive effect of Ondansetron and Dexamethasone on control of headache caused by local anesthetic from the lumbar in non-emergency cesarean section
Lack of consent
Candidate cesarean with general anesthesia
Drug allergy
Emergency cesarean section
Age
From 17 years old to 17 years old
Gender
Female
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
Evaluator, and data analyzer will not be aware of the groups. Only the person who makes the medications knows each group and its samples. the person who evaluates the outcome and analyzer are unaware of the medication given to each group.
Placebo
Used
Assignment
Parallel
Other design features
clinical trial and double blind
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Arak University Of Medical Sciences
Street address
Arak University Of Medical Sciences
City
Arak
Province
Markazi
Postal code
3814957558
Approval date
2016-12-12, 1395/09/22
Ethics committee reference number
IR.ARAKMU.MU.REC.1395.314
Health conditions studied
1
Description of health condition studied
elective cesarean section
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
headache
Timepoint
12, 24 and 48 hours after cesarean
Method of measurement
Visual Analogue Scale of pain
Secondary outcomes
1
Description
Blood pressure
Timepoint
Every 15 minute until end of recovery
Method of measurement
Sphygmomanometer (millimeter Hg)
2
Description
Heart rate
Timepoint
Every 15 minute until end of recovery
Method of measurement
Beat in minute
Intervention groups
1
Description
We inject 8 milligram Dexamethasone slow intravenously.
Category
Prevention
2
Description
We inject 8 milligram Ondansetron slow intravenously.
Category
Prevention
3
Description
We inject 8 milligram distilled water as placebo intravenously.