To evaluate the efficacy and safety of oral Nimodipine and IV milrinone combination therapy for management of cerebral spasm after aneurysmal subarachnoid hemorrhage.
after being informed about the study and potential risks. All patients giving written consent will be randomized by double-blind manner into 2groups each one containing 15 patients. Group 1(n =15 ):the patients will receive nimodipine (60 mg/4 hours) orally or via nasogastric tube In group 2(n =15 ): the patients will receive Oral Nimodipine (60 mg/4) will be given orally or in the gastric tube also from the first day of admission, then after the diagnosis of vasospasm is confirmed, start milrinone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
(60 mg/4 hours) orally or via nasogastric tube
Oral Nimodipine then after the diagnosis of vasospasm is confirmed, start milrinone bolus
Aculty of Medicine,Zagazig University
Zagazig, Sharqia Province, Egypt
Faculty of Medicine,Zagazig University
Zagazig, Zagazig, Elsharkia,egypt, Egypt
Concentration of transcutaneous cerebral mixed oxygen saturation
by forehead bilateral interconnected adhesive probes
Time frame: every 24 hours up to 1 week
Number of participants having cerebral infarction (cerebral infarction incidence)
detected by computed tomography
Time frame: every 48 hours up to 1 week
Number of participants restore of the previous conscious level and motor state(Percentage of drug success)
restore of the previous conscious level and motor state
Time frame: 1 hour after administration of milrinone and 2 hours after administration of triple H therapy
value of Glasgow coma scale
with minimum scale vlue of 3 is the worst and maximum value of 16 indicate better outcome
Time frame: every 24 hours up to total days of ICU and hospital stay
Number of participants develop one of adverse events
hypotension ,bradycardia,hypotesion
Time frame: after administration of the study drugs up to 30 days
Total ICU and hospital stay
Time frame: up to 30 days after administration of the study drugs
mortality rate
Number of participants died within 30 day after administration of the study drugs
Time frame: 30 day after administration of the study drugs
value of Modified Rankin scale
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Level 0: no symptoms Level 1: no significant disability, despite symptoms; able to perform all usual duties and activities Level 2: slight disability unable to perform all previous activities but able to look after own affairs without assistance Level 3: moderate disability; requires some help, but able to walk without assistance. Level 4: moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance Level 5: sever disability; bedridden, incontinent and requires nursing care and attention
Time frame: 3,6,12 monthes after drug administration
Glasgow Outcome Scale
1\. Dead: As a direct result of brain trauma, or … due to secondary complications or other complications" "2. Vegetative State: Patients who remain unresponsive and speechless…." "3. Severe Disability: The The patient is conscious but needs the assistance of another person for some activities of daily living every day.…." "4. Moderate Disability: Such a patient is able to look after himself at home, to get out and about to the shops and to travel by public transport. However, some previous activities, either at work or in social life, are now no longer possible by reason of either physical or mental deficit…." "5. Good Recovery: This indicates the capacity to resume normal occupational and social activities, although there may be minor physical or mental deficits…social outcome should be included in the assessment here, such as leisure activities and family relationships..
Time frame: 3,6,12 monthes after drug administration