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The effect of different intratechal pethidine on shivering after caesarian surgery

Protocol summary

Summary
After getting the approval of the local committee of ethics in Bushehr university of medical sciences 160 patients ASA 1 and 2 age between 15 and 50 who are candidates for caesarean section and signed informed consent were randomly allocated into four groups. One control group and 3 intervention groups. Group 1 received 10 mg bupivacaine Intratechaly, group 2 received 0.2 mg/kg pethidine plus 10 mg bupivacaine Intratechaly up to 2 cc, group 3 received 0.3 mg/kg pethidine plus 10 mg bupivacaine Intratechaly up to 2 cc, and group 4 received 0.4 mg/kg pethidine plus 10 mg bupivacaine Intratechaly up to 2 cc. Shivering, hemodynamic change, nausea and vomiting and pain will be recorded and compared among the study groups. The level of anesthesia in all four groups areT4.The site of needle insertion is T4-T5 by gauge number 24. The monitoring in the four 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

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138904101936N3
Registration date: 2010-10-15, 1389/07/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-10-15, 1389/07/23
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
Research committee of uiversity of medica science
Expected recruitment start date
2010-08-22, 1389/05/31
Expected recruitment end date
2010-09-23, 1389/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of different intratechal pethidine on shivering after caesarian surgery
Public title
The effect of different intratechal pethidine on shivering after caesarian surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All women age between 15 and 50 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 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 160
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 bushehr medical science
Street address
Siraf avenue
City
Bushehr
Postal code
Iran
Approval date
2010-07-01, 1389/04/10
Ethics committee reference number
BP/20/18/3/10587

Health conditions studied

1

Description of health condition studied
Shivering after spinal anesthesia
ICD-10 code
--
ICD-10 code description
--

Primary outcomes

1

Description
Post spinal shivering
Timepoint
90 minute
Method of measurement
observation

Secondary outcomes

1

Description
Post operative nausea and vomiting
Timepoint
90 minute
Method of measurement
observation

2

Description
Hemodynamic change (BP Change)
Timepoint
90 minute
Method of measurement
NIBP monitoring

3

Description
Core temperature change
Timepoint
90 minute
Method of measurement
core temperature monitoring

4

Description
Apgar score of neonate
Timepoint
In minute 5 and 10
Method of measurement
Observation

Intervention groups

1

Description
Intratechal injection of 0.2 mg/kg pethidine plus lidocaine
Category
Prevention

2

Description
intratechal injection of lidocaine 100 mg two cc
Category
Prevention

3

Description
intratechal injection of 0.3 mg/kg of pethidine plus lidocaine
Category
Prevention

4

Description
Intratechal injection of 0.4 mg/kg pethidine plus lidocaine
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Bentolhoda hospital
Full name of responsible person
Dr Najafi Anaraki
Street address
Fateme zahra hospital
City
Bushehr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research committee of medical science
Full name of responsible person
Dr Asadi
Street address
Siraf avenue
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research committee of 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bushehr university of medical science
Full name of responsible person
Dr Najafi Anaraki
Position
Assistant professor
Other areas of specialty/work
Street address
Siraf avenue
City
Bushehr
Postal code
Phone
+98 912 313 3519
Fax
Email
ARNA566@YAHOO.COM
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bushehr university of medical science
Full name of responsible person
Dr Najafi Anaraki
Position
Assistant professor
Other areas of specialty/work
Street address
Siraf avenue
City
Bushehr
Postal code
Phone
+98 912 313 3519
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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