Adrenergic blockade in patients with subarachnoid hemorrhage
|
Status:
Trial complete. Results published 6/82.
Purpose:
To study the effect of a combination of alpha-blockade and beta-blockade in patients with subarachnoid hemorrhage.
Interventions:
Phentolamine
Alpha-adrenergic-blocking agent.
|
Propranolol
Beta-adrenergic receptor antagonist (beta-blocker) antihypertensive
|
Location(s):
London, England
Design:
Randomized, placebo-controlled, double-blind trial of 134 patients at a single center.
Inclusion Criteria
Between 15 and 65 years of age, subarachnoid hemorrhage confirmed by lumbar puncture presenting within 48 hours of onset.
Exclusion Criteria
Already moribund, known hypertension, receiving antihypertensive medication, previous myocardial infarction or obstructive airways disease, already receiving adrenergic-blockade agents.
Patient Involvement:
The first 118 patients enrolled in the trial were randomized to receive either phentolamine (20 mg every 3 hours) and propranolol (80 mg every 8 hours) or placebo. The remaining 30 patients were randomized to receive propranolol (80 mg every 8 hours) or placebo. The drugs were administered orally for 3 weeks. 14 patients dropped out of the study, 6 from the treated group and 8 from the placebo group. After 1 year the study was extended to examine the effects of early operation in patients taking two tablets of long-acting propranolol daily (without alpha blockade). 70 patients were added to the original 134. These patients were randomized in a single-blind fashion to receive either propranolol and early operation, propranolol and late operation or placebo and late operation.
Primary Outcome:
Change in neurological deficit at 4 weeks compared to admission, deaths and disability (unable to work) at 1 year.
Results:
Analysis of patients who completed the study showed no significant differences between treatment groups. Trends in favor of the treated group (especially women) included fewer neurological deficits, episodes of clinical deterioration deaths and disabilities. Extension of study in patients undergoing operation revealed significantly fewer deaths (p = 0.026) and significantly less disability (p = 0.003) in the propranolol treated group than the control group.
Source of Information:
Br Med J (Clin Res Ed) 1982 Jun 5;284(6330):1661-4.
|
|
Web Links and Publications:
|
|
This information last updated on: 4/30/2001
|
Trials
Directories