After getting the approval of the local committee of ethics in Bushehr university of medical sciences 78 patients ASA 1 and 2 age between 15 and 45 who are candidates for caesarean section and signed informed consent were randomly allocated into two groups. Control group receive 12.5 mg bupivacaine plus 12.5 mg meperdie up to 3 cc Intratechaly, Intervention group receive 12.5 mg bupivacaine plus ./5 milliliter of normal saline up to 3 cc Intratechaly. In this group 12.5mg meperdie will be injected intravenously before operation. Shivering, hemodynamic change, nausea and vomiting and pain will be recorded and compared among the study groups. The level of anesthesia in all two groups is T4.The site of needle insertion is T4-T5 by gauge number 24. The monitoring in the two group were the same (NIBPM, Pulse oximetry, HR in minute 1, 3, 10, 20 , 30 , 45 and in recovery room. Shivering were classified as CROOSLY described. The primary end point is incidence of shivering in groups. The secondary endpoint is incidence of nausea and vomiting.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201301261936N11
Registration date:2013-02-06, 1391/11/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-06, 1391/11/18
Registrant information
Name
Abdolreza Najafi Anaraki
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1354 0088
Email address
najafianaraki@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of Medical Sciences
Expected recruitment start date
2013-02-05, 1391/11/17
Expected recruitment end date
2013-03-05, 1391/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intravenous meperdine vs intratechal meperdine on shivering during delivery under spinal anaesthesia
Public title
The effect of intravenous meperdine vs intratechal meperdine on shivering during delivery under spinal anaesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: all women age between 15 and 45 years who are candidates for caesarean section and signed informed consent are eligible to join the study. Exclusion criteria: any contra indication for R/A and those who are sensitive to opioid.
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
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
Bushehr University of Medical Sciences Ethics Committee
Street address
Bushehr, Bushehr University of Medical Sciences
City
Bushehr
Postal code
Approval date
2012-12-03, 1391/09/13
Ethics committee reference number
B-91-14-5
Health conditions studied
1
Description of health condition studied
Shivering after delivery
ICD-10 code
O99.8
ICD-10 code description
Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Post spinal shivering
Timepoint
60 minute
Method of measurement
observation
Secondary outcomes
1
Description
Post operative nausea and vomitting
Timepoint
45 minute
Method of measurement
Observation
Intervention groups
1
Description
Control group received 12.5 mg bupivacaine 0.05, intratechaly plus 12.5 mg pethidine, intratechaly up to 3 cc
Category
Treatment - Drugs
2
Description
Intervention group receive 12.5 mg bupivacaine 0.05, intratechaly plus 0.5 cc of normal saline up to 3 cc plus 12.5 mg pethidine, intravenously
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalig Fars hospital
Full name of responsible person
Abdolreza Najafianaraki
Street address
Bushehr University of Medical Sciences
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Majid Asadi
Street address
Bushehr University of Medical Sciences, Bushehr
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bushehr 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
Bushehr University of Medical Sciences
Full name of responsible person
Dr Abdolreza Najafianaraki
Position
Assistant Professor
Other areas of specialty/work
Street address
bushehr university of medical science
City
Bushehr
Postal code
Phone
+98 77 1252 6801
Fax
Email
dr.najafianaraki@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr Abdolreza Najafianaraki
Position
Assistant professor
Other areas of specialty/work
Street address
Bushehr university of medical science
City
Bushehr
Postal code
Phone
+98 77 1252 6801
Fax
Email
dr.najafianaraki@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr. Abdolreza Najafi Anaraki
Position
Assistant Professor
Other areas of specialty/work
Street address
Bushehr-Bushehr University of Medical Sciences
City
Bushehr
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)