The effect of general anesthesia with etomidate for decrease of signs of bone cement implantation syndrome compare with spinal amesthesia in cemented hip arthroplasty
This study is done for prevention and decrease of bone cement implantation syndromes. 160 patients under hip arthroplasty are studies that used cement for their surgery. The patients have a history of sensitivity to etomidate anaphylaxis to cement and patients with A. S. A class IV are excluded from study. this is an interventional study. the patients are divided randomly into two groups containing general anesthesia with etomidate and spinal anesthesia. vital signs are recorded before and after of induction of anesthesia. if this syndrome occurs time and grading and treatment of bone cement syndrome are recorded and comparison in both groups.
General information
Acronym
BCIS or bone cement Syndrome
IRCT registration information
IRCT registration number:IRCT2012091910882N1
Registration date:2012-12-17, 1391/09/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-17, 1391/09/27
Registrant information
Name
Ali Iravani
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
dairavani@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2012-10-22, 1391/08/01
Expected recruitment end date
2013-12-21, 1392/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of general anesthesia with etomidate for decrease of signs of bone cement implantation syndrome compare with spinal amesthesia in cemented hip arthroplasty
Public title
The effect of method of anesthesia in decrease of signs of bone cement implantation syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: The patient are candidate for hip arthroplasty; and use cement for their sergury. A. S.A class I-III;HB>10
Exclusion criteria:The pateint be sensitive to etomidate and cement;hip arthroplasty without cement;A. S. A class IV;revesion of hip prothes
Age
No age limit
Gender
Both
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
Kashan University of Medical Sciences
Street address
Beheshti Hospital, 5th Kilometer Ravand Bulv
City
Kashan
Postal code
Approval date
2012-10-17, 1391/07/26
Ethics committee reference number
2732/1/5/29/ب
Health conditions studied
1
Description of health condition studied
Bone cement implantation syndrome
ICD-10 code
M96.6
ICD-10 code description
Fracture of bone following insertion of orthopaedic implant, joint prosthesis, or bone plate
Primary outcomes
1
Description
blood pressure
Timepoint
induction of anesthesia, before insertion of cement, 5 minute and 10 minute after cement
Method of measurement
barometer(mm hg)
2
Description
puls rate
Timepoint
induction of anesthesia, before insertion of cement, 5 minute and 10 minute after cement
Method of measurement
puls oximetre
3
Description
arterial oxigen saturation
Timepoint
induction of anesthesia, before insertion of cement, 5 minute and 10 minute after cement
Method of measurement
puls oximetre
Secondary outcomes
1
Description
cardiac arrest and death
Timepoint
any time after insertion of cement
Method of measurement
vital signs
Intervention groups
1
Description
Patients under general anesthesia after receiving 500 cc Ringer lactate are inducted with Midazolam (0.3 mg / kg), Fentanyl (2 micg / kg) and Etomidate (0.3 mg / kg). The patients are intubated with Cisatra curium (0.15 mg/kg) and received maintenance dose of etomidate (10 micg / kg/ min).
Category
Prevention
2
Description
Patients undergoing spinal anesthesia after receiving 500 cc Ringer lactate are placed in the sitting or lateral position. Bupivacaine (20 mg) is injected into the subarachnoid space with using a No. 23 spinal needle through the space between the vertebral L3-L4 or L4-L5 or L5 - S1.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Dr Ali Iravani
Street address
Beheshti Hospital, 5th Kilometer Ghotbe Ravandi Bulv
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
Kashan University of Medical Sciences, 5 km Road Ravand
City
kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
kashan Univercity of Medical Sciences
Full name of responsible person
Ali Iravani
Position
Anesthesiologist resident
Other areas of specialty/work
Street address
Beheshti Hospital, 5th Kilometer Ravand Bulv
City
Kashan
Postal code
Phone
+98 35 1626 7752
Fax
Email
dairavani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan Univercity of Medical Sciences
Full name of responsible person
Mohammad Reza Razavizadeh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Beheshti Hospital, 5th Kilometer Ghotbe Ravandi Bulv
City
Kashan
Postal code
Phone
+98 36 1555 0026
Fax
Email
mr_razavi48@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Ali Iravani
Position
Resident of Anesthesia
Other areas of specialty/work
Street address
Beheshti Hospital, 5th Kilometer Ravand Bulv
City
Kashan
Postal code
Phone
+98 36 1555 0026
Fax
Email
dairavani@yahoo.com
Web page address
www.kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)