The propose of this study is assess the competitive effect of propofol and ketamin on complication after cesarean under spinal anesthesia during the year 2015. The statistical population included women candied of cesarean elective and sample size is 92. Inclusion criteria : age 18-35; term pregnancy; same surgeon and anesthesia; same dose of spinal anesthesia drug. The exclusion criteria : administration of general anesthesia drug in the absence of adequate spinal anesthesia ; systemic disease.In a randomized double blind clinical trial [blind for patients and researcher] the patients is assigned into four group: Placebo, propofol, ketamin and propofol plus ketamin. The parameters of pain, shivering, nausea and vomiting and drug consumption will be assessed with checklist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015061514668N4
Registration date:2015-09-18, 1394/06/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-18, 1394/06/27
Registrant information
Name
Molouk Jaafarpour
Name of organization / entity
Ilam University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 3222 7123
Email address
jaafarpour-m@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Ilam University of Medical Science
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison Effect of Propofol and Ketamine On complications after Cesarean Section under Spinal Anesthesia
Public title
The Comparison Effect of Propofol and Ketamine On complications after Cesarean Section under Spinal Anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria : age 18-35; term pregnancy; same surgeon and anesthesia; same dose of spinal anesthesia drug.
exclusion criteria : administration of general anesthesia drug; systemic disease
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
samples with Sealed envelope technique assigned in groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Ilam University of Medical Science
Street address
Pajohesh Blvd, Banganjab, Ilam
City
Ilam
Postal code
Approval date
2015-06-08, 1394/03/18
Ethics committee reference number
IR.MEDILAM.EC/94/H/277
Health conditions studied
1
Description of health condition studied
post cesarean complications
ICD-10 code
O82.9
ICD-10 code description
Delivery by caesarean section, unspecified
Primary outcomes
1
Description
pain
Timepoint
1,4,8,12 and 24 hrs after surgery
Method of measurement
Visual Analogue Scale (VAS) and checklist
2
Description
shivering
Timepoint
During recovery
Method of measurement
checklist and VAS
3
Description
Nausea & Vomiting
Timepoint
During recovery
Method of measurement
checklist and VAS
Secondary outcomes
1
Description
Brest feeding time
Timepoint
after surgery
Method of measurement
hrs
Intervention groups
1
Description
Intervention group : In propofol group 0.25 mg/kg will be injected interavenos after clamping of umbilical cord and fetus expulsion
Category
Treatment - Drugs
2
Description
Intervention group: In ketamin group 0.25 mg/kg will be injected interavenos after clamping of umbilical cord and fetus expulsion.
Category
Treatment - Drugs
3
Description
Intervention group: In ketofol group 25 mg propofol pulse 25 mg ketamin will be injected interavenos after clamping of umbilical cord and fetus expulsion.
Category
Treatment - Drugs
4
Description
Control group: In placebo group normal saline will be injected interavenos after clamping of umbilical cord and fetus expulsion
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mostafa Khomeini Hospital
Full name of responsible person
Molouk Jaafarpour
Street address
Ilam University of Medical Science
City
Ilam
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Ilam University of Medical Science
Full name of responsible person
Dr Koroosh Soleimannejad
Street address
Pajohesh Blvd, Banganjab
City
Ilam
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 of Ilam University of Medical Science