Effects of temporary clips on somatosensory evoked potentials in anterior circulation of brain aneurysm surgery
Design
The design of the study is a clinical trial with no control group and for 10 patients the intervention is done and blindness is not done.
Settings and conduct
In this research, all patients referred to the Hazrat Rasoul Akram hospital, who suffered from brain aneurysm will be enrolled. Effects of temporary clips on somatosensory evoked potentials in anterior circulation of brain aneurysm surgery will be investigated.
Participants/Inclusion and exclusion criteria
All patients referred to Rasoul Akram Hospital, who suffered from brain aneurysm, will be enrolled. Inclusion criteria: The patient's aneurysm is only related to the anterior circulation of the brain. Exclusion criteria: Patient with history of stroke, The patient with history of previous aneurysm surgery.
Intervention groups
The intervention is a temporary clips in anterior circulation of brain aneurysm surgery.
Main outcome variables
The amount of changes in brain electrical potential, The duration of blockage of the arteries with clips, Stroke
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171124037606N2
Registration date:2019-01-23, 1397/11/03
Registration timing:prospective
Last update:2019-01-23, 1397/11/03
Update count:0
Registration date
2019-01-23, 1397/11/03
Registrant information
Name
Alireza Tabibkhooei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2228
Email address
tabibkhooei.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of temporary clips on somatosensory evoked potentials in anterior circulation of brain aneurysm surgery
Public title
Effects of temporary somatosensory evoked potentials in brain aneurysm
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient's aneurysm is only related to the anterior circulation of the brain
Exclusion criteria:
Patient with history of stroke
The patient with history of previous brain aneurysm surgery
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
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
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-12-22, 1397/10/01
Ethics committee reference number
IR.IUMS.FMD.REC.1397.112
Health conditions studied
1
Description of health condition studied
Cerebral aneurysm
ICD-10 code
I67.1
ICD-10 code description
Cerebral aneurysm, nonruptured
Primary outcomes
1
Description
The amount of changes in brain electrical potential
Timepoint
Every 10 seconds
Method of measurement
With Somatosensory Evoked Potentials
2
Description
The duration of blockage of the arteries with clips
Timepoint
Continuously, from the time the clips is put up to remove it
Method of measurement
Based on patient records
3
Description
Stroke
Timepoint
During operation, after the completion of surgery, 3 days, 1 week and one month after surgery
Method of measurement
Based on patient records
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: temporary clips in anterior circulation of brain aneurysm surgery