Evaluation of the effect of local infiltration of Ropivacaine on hemodynamic status during the craniotomy on patients at the Khorramabad Shohada Ashayer hospital
This study is a clinical trial. Study population are patients under craniotomy in in the Khorramabad Shohada hospital with using general anesthesia. Patients were randomly divided into two groups: case and control. Patients are matched by age and gender. After monitoring between 3-5 minutes before induction, intravenous midazolam and fentanyl intravenously at a dose of 0.06mg/kg 3μg/kg, respictively, and Nesdonal at a dose of 5mg/kg and atracurium at dose 0.5mg/kg is administered to the patients. After 3-4 min laryngoscopy is done and tracheal tube fixed. Isoflurane gas is open with amount 1-1.5 percent. The systolic, diastolic and mean arterial blood pressure and heart rate are measured.7-10 min after fixation of tracheal tube the four item were measured. At the incision place in the case group, 10 ml of 0.5% Ropivacaine is topical infiltration. 30 seconds, 1, 3, 5 and 10 min after incision the four item were measures. At the end of surgery amount of drug and isoflurane gas are used is recorded. In the control group of normal saline solution in the same position and the same amount used.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014050316066N4
Registration date:2014-05-28, 1393/03/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-28, 1393/03/07
Registrant information
Name
Siavash Beiranvand
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 1221 5006
Email address
dr.beiranvand@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Sciences
Expected recruitment start date
2013-12-01, 1392/09/10
Expected recruitment end date
2014-01-30, 1392/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of local infiltration of Ropivacaine on hemodynamic status during the craniotomy on patients at the Khorramabad Shohada Ashayer hospital
Public title
Evaluation of the effect of local infiltration of Ropivacaine on hemodynamic status during the craniotomy on patients at the Khorramabad Shohada Ashayer hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: absence of underlying renal, hepatic, and consent to participate in the study. Exclusion criteria: not thrilled inclusion criteria and having a history of drug allergy .
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Lorestan University of Medical Sciences
Street address
Pardis Academic Complex
City
Khorramabad
Postal code
381351698
Approval date
2013-11-30, 1392/09/09
Ethics committee reference number
200/96196
Health conditions studied
1
Description of health condition studied
Patients undergoing craniotomy with general anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
vital sign(The systolic, diastolic and mean arterial blood pressure and heart rate)
Timepoint
vital sign(The systolic, diastolic and mean arterial blood pressure and heart rate):after intubation and 7-10 min after intubation and 30 second and 1,3,5,10 min after incision
Method of measurement
The systolic, diastolic and mean arterial blood pressure:mmHg,monitoring.Heart Rate:frequency.monitoring
2
Description
Narcotic drug
Timepoint
the end of surgery
Method of measurement
gram
3
Description
Isoflorane gas
Timepoint
the end of surgery
Method of measurement
%
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ropivacaine 0.5%, 1 ml in incision place (before incision), local infiltration
Category
Other
2
Description
Control group: normal salin solusion; 1 ml in incision place (before incision), local infiltration
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Ashayer Hospital
Full name of responsible person
Dr Siavash Beiranvand
Street address
Enqelab st.Shohada Ashayer Hospital
City
Khorramabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Lorestan University of Medical Sciences (Assistance of research & technology)
Full name of responsible person
Dr Mohamad Hasan Kayedi
Street address
Kamalvand Medical Sience university
City
Khorramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan University of Medical Sciences (Assistance of research & technology)
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
Lorestan University of Medical Sciences
Full name of responsible person
Dr Siavash Beiranvand
Position
Anesthesiologist
Other areas of specialty/work
Street address
Lorestan University of Medical Sciences
City
Khorramabad
Postal code
Phone
+98 66 1620 0155
Fax
Email
moradifars@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Dr. Siavash Beiranvand
Position
Anesthesiologist
Other areas of specialty/work
Street address
Lorestan University of Medical Sciences
City
Khorramabad
Postal code
Phone
+98 66 1620 0155
Fax
Email
moradifars@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Saba Moradifar
Position
General practitioner
Other areas of specialty/work
Street address
Lorestan medicine univercity
City
Khorramabad
Postal code
Phone
+98 66 1620 0155
Fax
Email
moradifars@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)