Objective: Compare the effect of two different doses of mepiridine intrathecal with placebo in patients who are in hospital in Sanandaj in 2015 by Caesarean section
Study design :
Randomized , double-blind , placebo- controlled , single-center
Inclusion criteria:
Elective cesarean section.
Fill the informed consent form
Physical condition corresponding to the class I and II anesthesia
Exclusion criteria:
Emergency cesarean
Pregnancy associated diseases such as hypertension, diabetes
Valvular heart disease
Ischemic heart disease
Pulmonary hypertension
Pre- eclampsia
Diabetes
Sample : 150
(B) intervention or interventions studied patients divided into three groups: the first group 2/5 mL bupivacaine 0.5% and 0/5 mm salin , the second group received 2/5 ml of bupivacaine 0/5% and 0/5ml mepridine ( 5 mg) and 2/5 mL of bupivacaine 0.5% and the third group Mepridine 0.5 ml ( 10 mg) was injected
(C) intervention : spinal anesthesia
(D)primary outcome: post anesthesia shivering, Core temperature
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015090223869N1
Registration date:2015-10-20, 1394/07/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-20, 1394/07/28
Registrant information
Name
Mokhtar Pouladi
Name of organization / entity
Medical University of Kurdistan
Country
Iran (Islamic Republic of)
Phone
+98 87 3182 7202
Email address
mokhtar.pouladi@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Kurdistan University of Medical Sciences
Expected recruitment start date
2015-09-16, 1394/06/25
Expected recruitment end date
2015-10-17, 1394/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison anti shivering effects between two different doses of intrathecal meperidine versus placebo in cesarean section
Public title
Effect of Mepridin on post cesarian section shivering
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Elective cesarean section ; Fill the informed consent form ; Physical condition corresponding to the class I and II anesthesia
Exclusion criteria: Emergency cesarean; Pregnancy associated diseases such as hypertension, diabetes ; Valvular heart disease ; Ischemic heart disease ; Pulmonary hypertension; Pre- eclampsia
Age
No age limit
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
Medical University of Kurdistan-Management Student Research
Street address
Pasdaran street
City
Sanandaj
Postal code
Approval date
2015-08-03, 1394/05/12
Ethics committee reference number
muk.rec.1394.144
Health conditions studied
1
Description of health condition studied
caesarean section
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section
Primary outcomes
1
Description
post anesthesia shivering
Timepoint
After intervention
Method of measurement
visual scale shivering
2
Description
Core temperature
Timepoint
before and After intervention
Method of measurement
using omernon termoscan
Secondary outcomes
1
Description
HR
Timepoint
Before injection and every 15 minutes during surgery
Method of measurement
using of HR recorded on monitoring
2
Description
peak anesthesia time
Timepoint
Before injection and every 15 minutes during surgery
Method of measurement
two ways alcohol cotton and pinprek
3
Description
Blood Pressure
Timepoint
Before injection and every 15 minutes during surgery
Method of measurement
using of BP recorded on monitoring
Intervention groups
1
Description
The first group injected 2/5 mL bupivacaine 0.5% and 0/5 ml salin
Category
Prevention
2
Description
The second group received 2/5 ml of bupivacaine 0/5% and 0/5ml mepridine ( 5 mg)
Category
Treatment - Drugs
3
Description
The third group recived 2/5 mL of bupivacaine 0.5% and Mepridine 0.5 ml ( 10 mg)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Women Operation Room of Sanandaj Besat Hospital
Full name of responsible person
Mokhtar Pouladi-Medical Student
Street address
Wakil four-way
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Kurdistan University of Medical Sciences
Full name of responsible person
Karim Naseri-Anesthesiologist
Street address
Pasdaran Street
City
Sanandaj
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 Kurdistan 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
Kurdistan University of Medical Science
Full name of responsible person
Mokhtar Pouladi
Position
Intern
Other areas of specialty/work
Street address
Razi Residence
City
Sanandaj
Postal code
Phone
+98 44 4323 0592
Fax
Email
mokhtar.pouladi@gmail
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of Mdical Sience
Full name of responsible person
Karim Naseri
Position
Anesthesiologist
Other areas of specialty/work
Street address
Besat Haspital
City
Sanandaj
Postal code
Phone
+98 44 4323 0592
Fax
Email
Bihoshi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kurdistan University of Medical Science
Full name of responsible person
Mokhtar Pouladi
Position
Intern
Other areas of specialty/work
Street address
Razi Residence
City
Sanandaj
Postal code
Phone
+44 43230592
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)