Analysis and Comparison of the Variations of Blood Flow velocity in Doppler Ultrasound of Brain Vessels before and after the Intra arterial Injection of Papaverine during the Operation of Patients Suffering from Brain Aneurysm in Al-Zahra Hospital, Isfahan, Iran during 2011-2012
Analysis and Comparison of the Variations of Blood Flow velocity in Doppler Ultrasound of Brain Vessels before and after the Intra arterial Injection of Papaverine during the Operation of Patients Suffering from Brain Aneurysm that decrease Blood Flow velocity couse to prevention & treat the vasospasm. The entrance criteria to the study included the followings: infliction to cerebral Aneurysm suffering from Sub Arachnoidhemorrhage and were candidates of surgical operation for any reason regardless of the time of hemorrhage; not being inflected to Parkinson's disease; not being in complete heart block A.V condition; not being inflicted to Glaucoma; not being pregnant and the patient`s consent. The patients that encountered brain death after the hemorrhage under Arachnoid were disregarded from the study. The procedure was as follows: the qualified patients were examined under the Microvascular Doppler Ultrasound (MDS) during the operation and before the Papaverine injection; and the blood flow velocity in cerebral arteries of these patients were measured, then 200mg Papaverine, by Insulin Syringe through the main arterials of brain proximal to Aneurysm, is injected intra arterially. Thirty minutes after the injection of medicine, the patients were examined by Doppler Ultrasound (MDS) again and of the arterial blood flowvelocity was measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013010411996N1
Registration date:2013-01-26, 1391/11/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-26, 1391/11/07
Registrant information
Name
Mohamad Motahari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1673 4669
Email address
m_motahari@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2011-04-09, 1390/01/20
Expected recruitment end date
2012-08-21, 1391/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Analysis and Comparison of the Variations of Blood Flow velocity in Doppler Ultrasound of Brain Vessels before and after the Intra arterial Injection of Papaverine during the Operation of Patients Suffering from Brain Aneurysm in Al-Zahra Hospital, Isfahan, Iran during 2011-2012
Public title
Analysis Injection of Papaverine in the Brain Vessels for to prevent some camplication of Brain bleeding
Purpose
Prevention
Inclusion/Exclusion criteria
The entrance criteria to the study included the followings: infliction to cerebral Aneurysm suffering from Sub Arachnoidhemorrhage and were candidates of surgical operation for any reason regardless of the time of hemorrhage; not being inflected to Parkinson's disease; not being in complete heart block A.V condition; not being inflicted to Glaucoma; not being pregnant and the patient`s consent. The patients that encountered brain death after the hemorrhage under Arachnoid were disregarded from the study.
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
medical university of Isfahan
Street address
st.hezarjerib, medical university of Isfahan
City
Isfahan
Postal code
Approval date
2011-02-20, 1389/12/01
Ethics committee reference number
389467
Health conditions studied
1
Description of health condition studied
Vasospasm of cerebral vessels
ICD-10 code
G45.9
ICD-10 code description
Vasospasm of cerebral vessels
Primary outcomes
1
Description
Decrease Blood Flow velocity
Timepoint
30 min
Method of measurement
Doppler Ultrasound sec/cm
Secondary outcomes
1
Description
Increase Blood Flow velocity
Timepoint
30 min
Method of measurement
Doppler Ultrasound
Intervention groups
1
Description
The procedure was as follows: the qualified patients were examined under the Microvascular Doppler Ultrasound (MDS) during the operation and before the Papaverine injection; and the blood flow velocity in cerebral arteries of these patients were measured, then 200mg Papaverine, by Insulin Syringe through the main arterials of brain proximal to Aneurysm, is injected intra arterially. Thirty minutes after the injection of medicine, the patients were examined by Doppler Ultrasound (MDS) again and of the arterial blood flowvelocity was measured.
Information of the patients were recorded in a checklist that included personal and case features of the patient, age, sex and the blood flowvelocity, before and after Papaverine injection. At the end, the data were analyzed by SPSS software version 20 using chi-square, two independent sample T test and paired sample T test.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital of Isfahan
Full name of responsible person
mohamad motahari
Street address
Dep. neurosurgery oh the Al-Zahra Hospital of Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Medical Univercity of Isfahan
Full name of responsible person
Ms Toghiani
Street address
st.Hezar jerib ,Medical Univercity of isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical Univercity of Isfahan
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
Medical Univesity of Isfahan
Full name of responsible person
ghasem baghershahi
Position
resident of neurosurgery
Other areas of specialty/work
Street address
st.Hezar Jerib, Medical University of Isfahan
City
Isfahan
Postal code
Phone
+98 31 1668 5555
Fax
0
Email
parsa86@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical University of Isfahan
Full name of responsible person
Mohamad Motahari
Position
resident of neurosurgery
Other areas of specialty/work
Street address
st.Hezar Jerib, Medical University of Isfahan
City
Isfahan
Postal code
Phone
+98 31 1668 5555
Fax
Email
m_motahari@resident.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medical University of Isfahan
Full name of responsible person
Ghasem Baghershahi
Position
Resident of neurosurgery
Other areas of specialty/work
Street address
st.Hezar Jerib, Medical University of Isfahan
City
Isfahan
Postal code
Phone
+98 311625555
Fax
Email
parsa86@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)