Spies 2009.

Trial name or title	Perioperative physostigmine prophylaxis for liver resection patients at risk for delirium and postoperative cognitive dysfunction: a prospective, randomised, controlled, double‐blinded, two‐armed single‐centre trial
Methods	Phase IV double‐blind randomised placebo‐controlled trial
Participants	Patients over 18 undergoing elective liver resection with or without additional elective surgery in the same session, able to provide informed consent, negative pregnancy testing (beta‐human chorionic gonadotrophin [B‐HCG]).
Interventions	During liver resection: 1. 24‐hour perioperative intravenous administration of physostigmine (0.02 mg/kg BW as bolus and 0.01 mg/kg BW/hr (for 24 hours) from the beginning of the operation 2. 24‐hour perioperative intravenous administration of placebo over 24 hrs.
Outcomes	Primary outcomes: Incident delirium (DSM‐IV criteria), measured preoperatively and up to hospital discharge, Cambridge Neurophysiological Test Automated Battery (CANTAB), measured preoperatively, on the 7th, 90th and 365th postoperative day Secondary outcomes: Delirium; Evaluation of intensive care unit performance, Length of postoperative hospital stay, Length of postoperative ICU stay, pain, postoperative complications and organ dysfunction, rate of systemic inflammatory response syndrome (SIRS) and infection, quality of life questionnaires, mortality, postoperative survival at 90 days, 6 months and one year, immune parameters, perioperative assessment of sleep stage, parameters of haematology, parameters of renal function.
Starting date	August 2009
Contact information	gerrit.fleige@charite.de
Notes	ISRCTN18978802 Anticipated end date: April 2016