title: Early treatment with risperidone for subsyndromal delirium after on-pump cardiac surgery in the elderly: a randomized trial.
abstract: BACKGROUND
  The aim of this randomized, parallel-arm trial was to study the effect of treating subsyndromal delirium with risperidone on the incidence of clinical delirium in elderly patients who underwent on-pump cardiac surgery.
  
  
  METHODS
  One hundred one patients aged 65 yr or older who experienced subsyndromal delirium after on-pump cardiac surgery were randomized using a computer-generated list to receive 0.5 mg risperidone (n = 51) or placebo (n = 50) every 12 h by mouth. Patients were assessed at 8 h by a blinded observer using the Intensive Care Delirium Screening Checklist, and those scoring more than 3 were evaluated by a blinded psychiatrist to confirm delirium. Patients in either group who experienced delirium were treated according to the same algorithm. Initially, risperidone was administered and if symptoms were not controlled, haloperidol was administered. The primary outcome was the proportion of patients who experienced delirium in either group.
  
  
  RESULTS
  Seven (13.7%) patients in the risperidone group experienced delirium versus 17 (34%) in the placebo group (P = 0.031) Competing-risks regression analysis showed that failure to treat subsyndromal delirium with risperidone was an independent risk factor for delirium (subhazard ratio, 3.83; 95% CI, 1.63-8.98; P = 0.002). Two (3.9%) patients in the risperidone group experienced extrapyramidal manifestations versus one (2%) in the placebo group (P = 1.0).
  
  
  CONCLUSIONS
  Administration of risperidone to elderly patients who experienced subsyndromal delirium after on-pump cardiac surgery was associated with significantly lower incidence of delirium. Larger studies are required to determine whether early administration of risperidone during the subsyndromal phase of delirium would influence the clinical course of such patients.
authors.affiliation: Department of Anesthesiology, Faculty of Medicine, Ain Shams University, Cairo, Egypt. drsmichel@hotmail.com
authors.forename: Sameh M
authors.initials: SM
authors.lastname: Hakim
authors.forename: Ahmed I
authors.initials: AI
authors.lastname: Othman
authors.forename: Dina O
authors.initials: DO
authors.lastname: Naoum
mesh_terms: D000368:Aged; D000768:Anesthesia, General; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001480:Basal Ganglia Diseases / Q000139:chemically induced / Q000453:epidemiology; D002315:Cardiopulmonary Bypass / Q000009:adverse effects*; D003422:Critical Care; D003693:Delirium / Q000188:drug therapy* / Q000209:etiology* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007902:Length of Stay; D008297:Male; D009483:Neuropsychological Tests; D011182:Postoperative Care; D011183:Postoperative Complications / Q000188:drug therapy* / Q000523:psychology; D011569:Psychiatric Status Rating Scales; D012044:Regression Analysis; D018967:Risperidone / Q000009:adverse effects / Q000627:therapeutic use*; D018401:Sample Size; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D018967:Risperidone