Early postoperative cognitive dysfunction and postoperative delirium after anaesthesia with various hypnotics

Study protocol for a randomised controlled trial - The PINOCCHIO trial

Federico Bilotta, Andrea Doronzio, Elisabetta Stazi, Luca Titi, Ivan O. Zeppa, Antonella Cianchi, Giovanni Rosa, Francesca P. Paoloni, Sergio Bergese, Irene Asouhidou, Polimnia Ioannou, Apolonia E. Abramowicz, Allison D. Spinelli, Ellise S. Delphin, Eugenia Ayrian, Vladimir Zelman, Philip Lumb

Research output: Contribution to journalArticle

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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/Design: 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.Discussion: 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.

Original languageEnglish (US)
Article number170
JournalTrials
Volume12
DOIs
StatePublished - Jul 6 2011

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Delirium
Hypnotics and Sedatives
Anesthesia
Randomized Controlled Trials
Fentanyl
Propofol
Cognitive Dysfunction
Cardiac Surgical Procedures
Ethics Committees
Postoperative Care
Hospital Costs
Consciousness
General Anesthesia
Cognition
Opioid Analgesics
Anesthetics
Nursing
Pharmacokinetics
Odds Ratio
Body Weight

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

Early postoperative cognitive dysfunction and postoperative delirium after anaesthesia with various hypnotics : Study protocol for a randomised controlled trial - The PINOCCHIO trial. / Bilotta, Federico; Doronzio, Andrea; Stazi, Elisabetta; Titi, Luca; Zeppa, Ivan O.; Cianchi, Antonella; Rosa, Giovanni; Paoloni, Francesca P.; Bergese, Sergio; Asouhidou, Irene; Ioannou, Polimnia; Abramowicz, Apolonia E.; Spinelli, Allison D.; Delphin, Ellise S.; Ayrian, Eugenia; Zelman, Vladimir; Lumb, Philip.

In: Trials, Vol. 12, 170, 06.07.2011.

Research output: Contribution to journalArticle

Bilotta, F, Doronzio, A, Stazi, E, Titi, L, Zeppa, IO, Cianchi, A, Rosa, G, Paoloni, FP, Bergese, S, Asouhidou, I, Ioannou, P, Abramowicz, AE, Spinelli, AD, Delphin, ES, Ayrian, E, Zelman, V & Lumb, P 2011, 'Early postoperative cognitive dysfunction and postoperative delirium after anaesthesia with various hypnotics: Study protocol for a randomised controlled trial - The PINOCCHIO trial', Trials, vol. 12, 170. https://doi.org/10.1186/1745-6215-12-170
Bilotta, Federico ; Doronzio, Andrea ; Stazi, Elisabetta ; Titi, Luca ; Zeppa, Ivan O. ; Cianchi, Antonella ; Rosa, Giovanni ; Paoloni, Francesca P. ; Bergese, Sergio ; Asouhidou, Irene ; Ioannou, Polimnia ; Abramowicz, Apolonia E. ; Spinelli, Allison D. ; Delphin, Ellise S. ; Ayrian, Eugenia ; Zelman, Vladimir ; Lumb, Philip. / Early postoperative cognitive dysfunction and postoperative delirium after anaesthesia with various hypnotics : Study protocol for a randomised controlled trial - The PINOCCHIO trial. In: Trials. 2011 ; Vol. 12.
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AU - Stazi, Elisabetta

AU - Titi, Luca

AU - Zeppa, Ivan O.

AU - Cianchi, Antonella

AU - Rosa, Giovanni

AU - Paoloni, Francesca P.

AU - Bergese, Sergio

AU - Asouhidou, Irene

AU - Ioannou, Polimnia

AU - Abramowicz, Apolonia E.

AU - Spinelli, Allison D.

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N2 - 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/Design: 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.Discussion: 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.

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