The clinical trial study of comparison intravenous pethidine and sterile water efficacy in prevention of shivering during cesarean section under spinal anesthesia
In this double blind randomized clinical trial, 80 ASAI pregnant patients of 15-40 years old who have uncomplicated pregnancy and are candidates for cesarean section with spinal anesthesia will be selected. Patients with history of pethidine allergy; countraindication of pethidine injection; history of opioid addiction or opioid abuse and patient with sever shivering will be excluded. All participants after filling an informed contest will be randomly assigned into two groups: Group P (40 patients) will receive 20mg (2cc) pethidine and group C will receive 2cc of sterile water both intravenously. Heart rate, blood pressure, vomiting, nausea and blood oxygen will be recorded before anesthesia and each 5 minute after anesthesia .The Severity of shivering after spinal anesthesia will be compared between the groups. Patients will be controlled for side effects such as vomiting; nausea and hypotension before and after anesthesia.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016040527242N1
Registration date:2016-08-19, 1395/05/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-19, 1395/05/29
Registrant information
Name
Manizhe Yousefi moghadam
Name of organization / entity
Sabzevar univerity of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4422 8595
Email address
yousefim1@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The clinical trial study of comparison intravenous pethidine and sterile water efficacy in prevention of shivering during cesarean section under spinal anesthesia
Public title
Pethidine efficacy in prevention of shivering during cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:ISI I pregnant women 15-40 years old with normal pregnancy that candidate for cesarean section under spinal anesthesia
Exclusion criteria:history of pethidine allergy; contraindication for pethidine injection; history of opioid addiction or opioid abuse; patient with sever shivering has been given drug
Age
From 15 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Sabzevar University of Medical Sciences
Street address
Central building of Sabzevar University of Medical Science ,Asadabadi Street,Sabzevar
City
Sabzevar
Postal code
Approval date
2015-08-03, 1394/05/12
Ethics committee reference number
ir.medsab.rec.1394.64
Health conditions studied
1
Description of health condition studied
Effect of intravenous pethidine on preventing post spinal anestesia shivering in cesarean section
ICD-10 code
O89.4
ICD-10 code description
O89.4
Primary outcomes
1
Description
Shivering
Timepoint
Before spinal anesthesia; 5 min after spinal anesthesia; every 10 min in operating room and recovery
Method of measurement
Grade 0 (no shivering) to grade 4 (involved whole body muscles)
Secondary outcomes
1
Description
Nausea
Timepoint
After pethidine injection
Method of measurement
visual
Intervention groups
1
Description
Patient in Group P received 20mg (2cc) pethidine intravenously before spinal anesthesia.
Category
Prevention
2
Description
Patient in Group C received 2cc strile water intravenously before spinal anesthesia.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sabzevar Shahidan Mobini Hospital
Full name of responsible person
Solmaz Dastres
Street address
Shahidan Mobini Hospital Kahefi street Sabzevar
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Manizheh Yousefi Moghadam
Street address
Taleghani Street Sabzevar
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Solmaz Dastras
Position
Bachellor of Anesthesiology
Other areas of specialty/work
Street address
Mobini Hospital Kashefi Street Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4423 8102
Fax
Email
solmasdastras@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Manizhe Yousefi Moghadam
Position
Anesthesiologist
Other areas of specialty/work
Street address
Mobini Hospital Kashefi Street Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4423 8100
Fax
Email
yousefim@medsab.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Elham Izanoo
Position
Other areas of specialty/work
Street address
Taleghani Street Sabzevar
City
Sabzevar
Postal code
Phone
+98 81 4423 1003
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)