The aim of this study is to investigate the effect of intravenous ketamine during ceasarian on score of post partum depression in Hospitals of Rafsanjan University of Medical Sciences 2016. The population includes all women who scheduled for cesarean. Inclusion criteria is no contraindications for ketamine use and they are excluded If they Use Antidepressants. Sample size is estimated 53 in each group according to previous studies and statistical formula. one stage intervention is applied at the time of induction of anesthesia and The control group will receive only anesthetic without ketamine. Study instruments include a questionnaire for demographic variables and Edinburgh questionnaire. Data were collected before starting intervention actively and Two weeks and four weeks after the intervention by phone.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122726971N2
Registration date:2017-07-16, 1396/04/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-16, 1396/04/25
Registrant information
Name
Marzeyeh Loripoor
Name of organization / entity
Rafsanjan University Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 4950
Email address
m.loripoor@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
govermental
Expected recruitment start date
2016-08-31, 1395/06/10
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating The Effect Of Intravenous Ketamine During Ceasarian On Score Of Post Partum Depression
Public title
Effect Of Ketamin On Postpartum Depression
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Iranian Woman Condidian for Elective Cesarian Except Emergent Cesarian Section, Due To Lack Of Awareness Of The Mother Disease , Ketamin Is Therefore Contraindicated.
General Anesthesia.
Not Contraindicated To Receive Ketamine ,Such As : Lack Of Cardiovascular Disease, Fetal Disorders Such As : Preterm Delivery , No History Of Psychiatric Disorders Except For Post Partum Depression , Central Nerve System Disorders ( Increase Intra Cranial Pressure , History Of Cerebral Hemorrhage , Cerebrovascular Disease)
Hyperthyroidism
Informed Consent To Participate In The Study
Exclude Criteria: Dissatisfaction And Failure To Answer The Questions.
Use Of Antidepressant , The Use Of Sigarettes , Alcohol And Drug Addiction.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Rafsanjan University Of Medical Sciences
Street address
Imam Ali Blvd, University of Medical Sciences, Rafsanjan
City
Rafsanjan
Postal code
7717932777
Approval date
2016-01-09, 1394/10/19
Ethics committee reference number
IR.RUMS.REC.1394.166
Health conditions studied
1
Description of health condition studied
PostPartum Depression
ICD-10 code
F53.0
ICD-10 code description
Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified
Primary outcomes
1
Description
Post Partum Depression
Timepoint
Before,2 week , 4 Week After Cesarian Section
Method of measurement
Edinburg Questioner
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, in addition to anesthetics, ketamine is also given as half a milligram per kilogram of body weight and The frequency of one-step intervention is at the time of induction of anesthesia.
Category
Treatment - Drugs
2
Description
Control Group: In this group of 3-5 mg of sodium thiopental will be used.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abi Talib Hospital And NickNafs Zayeshgah Rafsanjan
Full name of responsible person
Dr.Majid Kazemi
Street address
Imam Ali Blvd, University of Medical Sciences, Rafsanjan
City
Rafsanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For Research Rafsanjan University Medical Science
Full name of responsible person
Dr Hamid Hakimi
Street address
Imam Ali Blvd, University of Medical Sciences, Rafsanjan
City
Rafsanjan
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 Rafsanjan University Medical Science
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
Rafsanjan Univarcity Of Medical Sciences
Full name of responsible person
Marzeyeh Loripoor
Position
Phd Of Reproductive Health- Assistant Professor
Other areas of specialty/work
Street address
Jomhouri Eslami Bolv, Faculty of Nursing Midwifery, Rafsanjan
City
Rafsanjan
Postal code
7717932777
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
m.loripoor@rums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan Univercity Of Medical Siences
Full name of responsible person
Marzeyeh Loripoor
Position
Phd
Other areas of specialty/work
Street address
Jomhouri Eslami Bolv, Faculty of Nursing Midwifery, Rafsanjan
City
Rafsanjan
Postal code
7717932777
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
m.loripoor@rums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)