Rivastigmine for the prevention of postoperative delirium in elderly patients undergoing elective cardiac surgery--a randomized controlled trial.
OBJECTIVE
Cardiac surgery is frequently followed by postoperative delirium, which is associated with increased 1-year mortality, late cognitive deficits, and higher costs. Currently, there are no recommendations for pharmacologic prevention of postoperative delirium. Impaired cholinergic transmission is believed to play an important role in the development of delirium. We tested the hypothesis that prophylactic short-term administration of oral rivastigmine, a cholinesterase inhibitor, reduces the incidence of delirium in elderly patients during the first 6 days after elective cardiac surgery.


METHODS
: Double-blind, randomized, placebo-controlled trial.


METHODS
One Swiss University Hospital.


METHODS
One hundred twenty patients aged 65 or older undergoing elective cardiac surgery with cardiopulmonary bypass.


METHODS
Patients were randomly assigned to receive either placebo or 3 doses of 1.5 mg of oral rivastigmine per day starting the evening before surgery and continuing until the evening of the sixth postoperative day.


RESULTS
The primary predefined outcome was delirium diagnosed with the Confusion Assessment Method within 6 days postoperatively. Secondary outcome measures were the results of daily Mini-Mental State Examinations and clock drawing tests, and the use of a rescue treatment consisting of haloperidol and/or lorazepam in patients with delirium. Delirium developed in 17 of 57 (30%) and 18 of 56 (32%) patients in the placebo and rivastigmine groups, respectively (p = 0.8). There was no treatment effect on the time course of Mini-Mental State Examinations and clock drawing tests (p = 0.4 and p = 0.8, respectively). There was no significant difference in the number of patients receiving haloperidol (18 of 57 and 17 of 56, p = 0.9) or lorazepam (38 of 57 and 35 of 56, p = 0.6) in the placebo and rivastigmine groups, respectively.


CONCLUSIONS
This negative or, because of methodologic issues, possibly failed trial does not support short-term prophylactic administration of oral rivastigmine to prevent postoperative delirium in elderly patients undergoing elective cardiac surgery with cardiopulmonary bypass.
Gamberini
Melanie
M
Department of Anesthesia, University Hospital Basel, Basel, Switzerland.
Bolliger
Daniel
D
Lurati Buse
Giovanna A
GA
Burkhart
Christoph S
CS
Grapow
Martin
M
Gagneux
Alexa
A
Filipovic
Miodrag
M
Seeberger
Manfred D
MD
Pargger
Hans
H
Siegemund
Martin
M
Carrel
Thierry
T
Seiler
Walter O
WO
Berres
Manfred
M
Strebel
Stephan P
SP
Monsch
Andreas U
AU
Steiner
Luzius A
LA