Patients who were schedule for elective craniotomy for intracranial tumors surgeries and aged between 18 to 65 yr enrolled in this study. Patients who had history of head trauma, previous craniotomy, documented allergy to bupivacaine and uncontrolled hypertension were excluded from the study. Patients were enrolled to receive either 20 ml of 0.25% bopivacaine( intervention group) or 20 ml of 0.9% normal saline( control group). Before the induction of general anesthesia, standard monitoring consisted of electrocardiography, heart rate, pulse oximetry, systolic BP, diastolic BP, and mean arterial pressure (MAP) were performed. An arterial catheter was inserted into right radial artery for BP monitoring and blood sampling.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111138087N1
Registration date:2011-12-01, 1390/09/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-01, 1390/09/10
Registrant information
Name
Saber Aminzadeh
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 918 332 3402
Email address
aminzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-03-10, 1390/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of subcutaneous infiltration of 0.5% bupivacaien on the c-reactive protein titer and hemodynamic parameters after craniotomy
Public title
The impact of subcutaneous infiltration of 0.5% bupivacaien on the c-reactive protein titer and hemodynamic parameters after craniotomy
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:being candidate for craniotomy and age between18 to 65 years.
Exclusion criteria: need for emergency surgery ; previous craniotomy and Diabetes Melitus
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Tehran University of Medical Sciences
Street address
Sixth floor, Main buiding of Tehran University of Medical Sciences, Keshavarz blv.
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
686
Health conditions studied
1
Description of health condition studied
Craniotomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Heart Rate
Timepoint
Before, 1,5,10 and15 minuts after surgery
Method of measurement
Objective Record
2
Description
C-reactive protine
Timepoint
Before surgery, 24 and 48 Hours after surgery
Method of measurement
Plasma Sample
3
Description
Mean Arterial Pressure
Timepoint
Before, 1, 5,10 and 15 minuts after surgery
Method of measurement
Objective Record
Secondary outcomes
1
Description
Tachycardia
Timepoint
Before suegery, 1; 5 10 and 15 minuts after surgery
Method of measurement
Obgective Recorde
Intervention groups
1
Description
Subcutaneous injection of 20 ml o.9% normal saline
Category
Placebo
2
Description
Subcutaneous Injection of Bupivacaien 25%
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Reza Moharer shariate
Street address
Tehran university of medical sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Saber Aminzadeh
Position
MD
Other areas of specialty/work
Street address
Sina Hospital, Hassan Abad sq.
City
Tehran
Postal code
Phone
+98 83 2722 7544
Fax
Email
AMINZADEH@RAZI.TUMS.AC.IR
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saber Aminzadeh
Position
MD
Other areas of specialty/work
Street address
Sina Hospital, Hassan Abad sq.
City
Tehran
Postal code
Phone
+98 83 2722 7544
Fax
Email
AMINZADEH@RAZI.TUMS.AC.IR
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saber Aminzadeh
Position
MD
Other areas of specialty/work
Street address
Sina Hospital, Hassan Abad sq.
City
Tehran
Postal code
Phone
+98 83 2722 7544
Fax
Email
AMINZADEH@RAZI.TUMS.AC.IR
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)