Early postoperative cognitive dysfunction and postoperative delirium after anaesthesia with various hypnotics: study protocol for a randomised controlled trial--the PINOCCHIO trial

• Published in: Current controlled trials in cardiovascular medicine 2011-07, Vol.12 (1), p.170-170, Article 170
• Main Authors: Bilotta, Federico, Doronzio, Andrea, Stazi, Elisabetta, Titi, Luca, Zeppa, Ivan Orlando, Cianchi, Antonella, Rosa, Giovanni, Paoloni, Francesca Paola, Bergese, Sergio, Asouhidou, Irene, Ioannou, Polimnia, Abramowicz, Apolonia Elisabeth, Spinelli, Allison, Delphin, Ellise, Ayrian, Eugenia, Zelman, Vladimir, Lumb, Philip
• Format: Article
• Language: English
• Subjects: Anesthesia, General - adverse effects; Anesthesia, General - methods; Anesthetics, Inhalation - administration & dosage; Anesthetics, Inhalation - adverse effects; Anesthetics, Intravenous - administration & dosage; Anesthetics, Intravenous - adverse effects; Brain surgery; Clinical trials; Cognition - drug effects; Cognition Disorders - chemically induced; Cognition Disorders - diagnosis; Cognition Disorders - psychology; Complications; Complications and side effects; Delirium; Delirium - chemically induced; Delirium - diagnosis; Delirium - psychology; Dosage and administration; Double-Blind Method; Drug dosages; Fentanyl; Fentanyl - adverse effects; Gas flow; General anesthesia; Hospital costs; Humans; Hypnotics; Hypnotics and Sedatives - administration & dosage; Hypnotics and Sedatives - adverse effects; Hypotension; Intubation; Isoflurane - adverse effects; Isoflurane - analogs & derivatives; Italy; Local anesthesia; Methyl Ethers - adverse effects; Mortality; Narcotics; Neuropsychological Tests; Odds Ratio; Patients; Propofol - adverse effects; Prospective Studies; Research Design; Risk Assessment; Risk Factors; Sedatives; Study Protocol; Surgery; Time Factors; Treatment Outcome
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/1745-6215-12-170

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. 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. 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.