Protocol summary

Summary
The aim of this study was to evaluate the effect of dexamethasone and endonestrone on patients in three different groups. Inclusion criteria include gender, pregnancy, cesarean section and exit criteria including headache, nausea and vomiting. The study volume was 150 people. The intervention has an effect on the dexamethasone, andandonestrone and placebo exposure to the studied groups before and after the time of spinal anesthesia.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017022532768N1
Registration date: 2017-11-19, 1396/08/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
Mozhdeh Ghaffari
Name of organization / entity
Islamic Azad University of Ardabil
Country
Iran (Islamic Republic of)
Phone
+98 45 3372 8020
Email address
mozhdeh.ghaffari70@gmail.com
Recruitment status
Recruitment complete
Funding source
Deputy of Research of Islamic Azad University
Expected recruitment start date
2000-01-01, 1378/10/11
Expected recruitment end date
2008-01-01, 1386/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison Review of The Effects of Dexamethasone and Ondansetron Intravenous on Preventing Headache after Spinal Sedation of Patients under a Cesrean Section.
Public title
A Comparison of The Effects of Dexamethasone and Ondansetron Intravenous on Preventing Headache of Patients Under a Cesarean Section
Purpose
Prevention
Inclusion/Exclusion criteria
Entry criteria: Female: Pregnant: Satisfaction for drug injection Exit criteria: Migraine disease: history of headache
Age
From 1 year old to 1 year old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
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
The Ethics Committee of Islamic Azad University of Ardebil
Street address
No 342, Ardabil University of Medical Sciences, Ayatollah Moghadas Ardebi St, Shahid Moadi Ave, Ardabi, IRAN
City
Ardabil
Postal code
5615731567
Approval date
2017-09-23, 1396/07/01
Ethics committee reference number
IR.IAU.ARDABIL.REC.1395.19

Health conditions studied

1

Description of health condition studied
Delivery with Cesarean Section
ICD-10 code
O82.9
ICD-10 code description
Delivery by Caesarean Section, Unspecified

2

Description of health condition studied
Headache Caused by Spinal / Epidural Anesthesia
ICD-10 code
O74.5
ICD-10 code description
Spinal and Epidural Anaesthesia-Induced Headache During Labour and Delivery

Primary outcomes

1

Description
headache
Timepoint
Before and after the spinal anesthesia
Method of measurement
questionnaire

2

Description
nausea
Timepoint
Before and after the spinal anesthesia
Method of measurement
questionnaire

3

Description
vomit
Timepoint
Before and after the spinal anesthesia
Method of measurement
questionnaire

Secondary outcomes

1

Description
bradycardia
Timepoint
Before and after the spinal anesthesia
Method of measurement
ECG device

2

Description
hypotention
Timepoint
Before and after the spinal anesthesia
Method of measurement
barometer

3

Description
headach
Timepoint
Beforethe spinal anesthesia
Method of measurement
questionnaire

4

Description
nausea
Timepoint
Before the spinal anesthesia
Method of measurement
questionnaire

Intervention groups

1

Description
dexamethason,8 mg,IV,befor spinal anesthesia
Category
Prevention

2

Description
ondansetron,4 mg,IV,befor spinal anesthesia
Category
Prevention

3

Description
Control group: No special drug injection
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Alavi Hospital
Full name of responsible person
Mozhdeh Ghafari
Street address
No 6, Ayatollah Moghadas Ardebi St, , Shahid Moadi Ave, Ardabi, IRAN
City
Ardabil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Research of Islamic Azad University
Full name of responsible person
Masood Fardin
Street address
No 342, Ardabil University of Medical Sciences, AyatollahMoghadas Ardebi St, Shahid Moadi Ave, Ardabi, IRAN
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Islamic Azad 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
Islamic Azad University of Ardabil Branch
Full name of responsible person
Mozhdeh Ghaffari
Position
Medical Student
Other areas of specialty/work
Street address
No 342, Ardabil University of Medical Sciences, AyatollahMoghadas Ardebi St, Shahid Moadi Ave, Ardabi, IRAN
City
Ardabil
Postal code
5615731567
Phone
+98 45 3372 8020
Fax
+98 45 3372 7799
Email
mozhdeh.ghaffari70@gmail.com
Web page address
www.iauardabil.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University of Ardabil Branch
Full name of responsible person
Mozhdeh Ghaffari
Position
Medical Student
Other areas of specialty/work
Street address
No 342, Ardabil University of Medical Sciences, Ayatollah Moghadas Ardebi St, Shahid Moadi Ave, Ardabi, IRAN
City
Ardabil
Postal code
5615731567
Phone
+98 45 3372 8020
Fax
+98 45 3372 7799
Email
mozhdeh.ghaffari70@gmail.com
Web page address
www.iauardabil.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University of Ardabil Branch
Full name of responsible person
Mozhdeh Ghaffari
Position
Medical Student
Other areas of specialty/work
Street address
No 342, Ardabil University of Medical Sciences, Ayatollah Moghadas Ardebi St, Shahid Moadi Ave, Ardabi, IRAN
City
Ardabil
Postal code
5615731567
Phone
+98 45 3372 8020
Fax
+98 45 3372 7799
Email
mozhdeh.ghaffari70@gmail.com
Web page address
www.iauardabil.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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