The main objective: To determine the effect of intravenous propofol headache after spinal anesthesia for cesarean section.
Study design: non-random.
Inclusion criteria: pregnant women. Aged 18 -36. ASA class I, II.
Exclusion criteria: history of headache. Housing consumption. opioid addiction . pulmonary/ heart disease. Diabetes. Other diseases that need treatment.
Sample size: 120 women pregnant.
After spinal anesthesia in left lateral position by Quincke spinal needle 25 in the first group after leaving baby propofol infuses dy pump at a rate of 30 micrograms per kilogram per minute for 30 minutes is injected through the green angiocut.The control group did not receive the drug in both groups headache severity in patients after surgery is measured by an anesthesiologist immediately after entering the recovery room and hours 1, 6, 12, 18, 24 after the discharge.The visual analogue scale of pain was measured.
In case of headache patients with conventional treatment includes bed rest, hydration, use of analgesics, which includes acetaminophen codeine In this study, (300 mg acetaminophen and 20 mg codeine) administered every 6 hours using a corset.
The patient is said to be visited until discharge from the hospital a week later with an anesthesiologist by a phone call if notify headache
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201603131616N5
Registration date:2016-04-29, 1395/02/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-29, 1395/02/10
Registrant information
Name
Parisa Golfam
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6332
Email address
pgolfam@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy of intravenouse propofol on post dural puncture headache incidence after cesarian section
Public title
Evaluation the efficacy of intravenouse propofol on post dural puncture headache incidence after cesarian section
Purpose
Prevention
Inclusion/Exclusion criteria
Exclusion criteria: history of headache. Housing consumption. opioid addiction . pulmonary/ heart disease. Diabetes. Other diseases that need treatment
Inclusion criteria: pregnant women. Aged 18 -36. ASA class I, II.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences Ethics Committee
Street address
The central building , martyr Beheshti blvd.
City
Kermanshah
Postal code
6715847141
Approval date
2014-10-14, 1393/07/22
Ethics committee reference number
31546
Health conditions studied
1
Description of health condition studied
Postdural Puncture Headache
ICD-10 code
G97.1
ICD-10 code description
Postdural Puncture Headache
Primary outcomes
1
Description
Headache
Timepoint
1,6,18,24 hours and 2,3,4,5,6,7 days after spinal anesthesia
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After spinal anesthesia by left latral with Quincke spinal needle number 25 ,After leaving the infant propofol infuses with a pump at a rate of 30 micrograms per kilogram per minute for 30 minutes is injected through the IV green.The researcher must do completely control of BP, PR, RR, ECG,consciousness .
Category
Prevention
2
Description
In the control group no intervention was done
The researcher must do completely control of BP, PR, RR, ECG,consciousness .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Rasoul Mahdavi Jafari
Street address
Sorkhe lijhe street
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
The central building , Martyr Beheshti blvd.
City
Kermanshah
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, Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Rasoul Mahdavi Jafari
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences The central building Beheshti Blvd.
City
Kermanshah
Postal code
6714415333
Phone
+98 83 3427 6308
Fax
+98 83 3427 6343
Email
mahdjaf@gmail.com mahdjaf51@gmail.com
Web page address
http//:www.kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Parisa Golfam
Position
Assistant Professor
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
6714415333
Phone
+98 83 3427 6308
Fax
+98 83 3427 6343
Email
pargolfam@yahoo.com pgolfam@kums.ac.ir
Web page address
http://www.kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Rasoul Mahdavi Jafari
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences Central Building Beheshti Blvd.
City
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 4434
Fax
+98 83 3835 5925
Email
mahdjaf@gmail.com mahdjaf51@gmail.com
Web page address
http://www.kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)