Milrinone, Oral Nimodipine, Vascular Spasm After Traumatic Subarachnoidhaemorrhage
Conditions
Keywords
milrinone Oral Nimodipine
Brief summary
To evaluate the efficacy and safety of oral Nimodipine and IV milrinone combination therapy for management of cerebral spasm after aneurysmal subarachnoid hemorrhage.
Detailed description
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.
Interventions
DRUGnimodipine
(60 mg/4 hours) orally or via nasogastric tube
DRUGOral Nimodipine and milrinone
Oral Nimodipine then after the diagnosis of vasospasm is confirmed, start milrinone bolus
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
double
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients admitted to our surgical ICU * aged between (18-60) years old * World Federation of Neurological Surgeons grades 1-3 Grades
Exclusion criteria
* Aneurysmal SAH * SAH with Fisher Grade I and IV, * World Federation of Neurological Surgeons grade IV & V * No informed consent, * peripheral vascular disease * Cardiac disease (heart block, severe valvular stenosis, cardiomyopathothy , ejection fraction\<40%), Renal impairment (serum creatinine ≥ 1.4 mg.L-1), Hemodynamic instability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of transcutaneous cerebral mixed oxygen saturation | every 24 hours up to 1 week | by forehead bilateral interconnected adhesive probes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants restore of the previous conscious level and motor state(Percentage of drug success) | 1 hour after administration of milrinone and 2 hours after administration of triple H therapy | restore of the previous conscious level and motor state |
| value of Glasgow coma scale | every 24 hours up to total days of ICU and hospital stay | with minimum scale vlue of 3 is the worst and maximum value of 16 indicate better outcome |
| Number of participants develop one of adverse events | after administration of the study drugs up to 30 days | hypotension ,bradycardia,hypotesion |
| Number of participants having cerebral infarction (cerebral infarction incidence) | every 48 hours up to 1 week | detected by computed tomography |
| mortality rate | 30 day after administration of the study drugs | Number of participants died within 30 day after administration of the study drugs |
| value of Modified Rankin scale | 3,6,12 monthes after drug administration | 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 |
| Glasgow Outcome Scale | 3,6,12 monthes after drug administration | 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.. |
| Total ICU and hospital stay | up to 30 days after administration of the study drugs | — |
Countries
Egypt
Outcome results
None listed