title: Early postoperative cognitive dysfunction and postoperative delirium after anaesthesia with various hypnotics: study protocol for a randomised controlled trial--the PINOCCHIO trial.
abstract: BACKGROUND
  Postoperative delirium can result in increased postoperative morbidity and mortality, major demand for postoperative care and higher hospital costs. Hypnotics serve to induce and maintain anaesthesia and to abolish patients' consciousness. Their persisting clinical action can delay postoperative cognitive recovery and favour postoperative delirium. Some evidence suggests that these unwanted effects vary according to each hypnotic's specific pharmacodynamic and pharmacokinetic characteristics and its interaction with the individual patient.We designed this study to evaluate postoperative delirium rate after general anaesthesia with various hypnotics in patients undergoing surgical procedures other than cardiac or brain surgery. We also aimed to test whether delayed postoperative cognitive recovery increases the risk of postoperative delirium.
  
  
  METHODS
  After local ethics committee approval, enrolled patients will be randomly assigned to one of three treatment groups. In all patients anaesthesia will be induced with propofol and fentanyl, and maintained with the anaesthetics desflurane, or sevoflurane, or propofol and the analgesic opioid fentanyl.The onset of postoperative delirium will be monitored with the Nursing Delirium Scale every three hours up to 72 hours post anaesthesia. Cognitive function will be evaluated with two cognitive test batteries (the Short Memory Orientation Memory Concentration Test and the Rancho Los Amigos Scale) preoperatively, at baseline, and postoperatively at 20, 40 and 60 min after extubation.Statistical analysis will investigate differences in the hypnotics used to maintain anaesthesia and the odds ratios for postoperative delirium, the relation of early postoperative cognitive recovery and postoperative delirium rate. A subgroup analysis will be used to categorize patients according to demographic variables relevant to the risk of postoperative delirium (age, sex, body weight) and to the preoperative score index for delirium.
  
  
  CONCLUSIONS
  The results of this comparative anaesthesiological trial should whether each the three hypnotics tested is related to a significantly different postoperative delirium rate. This information could ultimately allow us to select the most appropriate hypnotic to maintain anaesthesia for specific subgroups of patients and especially for those at high risk of postoperative delirium. REGISTERED AT TRIAL.GOV NUMBER: ClinicalTrials.gov: NCT00507195.
authors: Department of Anaesthesiology, Critical Care and Pain Medicine, Sapienza University of Rome, Policlinico Umberto I, Rome, Italy. bilotta@tiscali.it
authors: Federico
authors: F
authors: Bilotta
authors: Andrea
authors: A
authors: Doronzio
authors: Elisabetta
authors: E
authors: Stazi
authors: Luca
authors: L
authors: Titi
authors: Ivan Orlando
authors: IO
authors: Zeppa
authors: Antonella
authors: A
authors: Cianchi
authors: Giovanni
authors: G
authors: Rosa
authors: Francesca Paola
authors: FP
authors: Paoloni
authors: Sergio
authors: S
authors: Bergese
authors: Irene
authors: I
authors: Asouhidou
authors: Polimnia
authors: P
authors: Ioannou
authors: Apolonia Elisabeth
authors: AE
authors: Abramowicz
authors: Allison
authors: A
authors: Spinelli
authors: Ellise
authors: E
authors: Delphin
authors: Eugenia
authors: E
authors: Ayrian
authors: Vladimir
authors: V
authors: Zelman
authors: Philip
authors: P
authors: Lumb
mesh_terms: D000768:Anesthesia, General / Q000009:adverse effects* / Q000379:methods; D018685:Anesthetics, Inhalation / Q000008:administration & dosage / Q000009:adverse effects*; D018686:Anesthetics, Intravenous / Q000008:administration & dosage / Q000009:adverse effects*; D003071:Cognition / Q000187:drug effects*; D003072:Cognition Disorders / Q000139:chemically induced* / Q000175:diagnosis / Q000523:psychology; D003693:Delirium / Q000139:chemically induced* / Q000175:diagnosis / Q000523:psychology; D000077335:Desflurane; D004311:Double-Blind Method; D005283:Fentanyl / Q000009:adverse effects; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage / Q000009:adverse effects*; D007530:Isoflurane / Q000009:adverse effects / Q000031:analogs & derivatives; D007558:Italy; D008738:Methyl Ethers / Q000009:adverse effects; D009483:Neuropsychological Tests; D016017:Odds Ratio; D015742:Propofol / Q000009:adverse effects; D011446:Prospective Studies; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D000077149:Sevoflurane; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018685:Anesthetics, Inhalation; D018686:Anesthetics, Intravenous; D006993:Hypnotics and Sedatives; D008738:Methyl Ethers; D000077149:Sevoflurane; D000077335:Desflurane; D007530:Isoflurane; D005283:Fentanyl; D015742:Propofol