Early postoperative cognitive dysfunction and postoperative delirium after anaesthesia with various hypnotics: study protocol for a randomised controlled trial - The PINOCCHIO trial
2011

Study Protocol for the PINOCCHIO Trial on Postoperative Delirium

Sample size: 825 publication null Evidence: moderate

Author Information

Author(s): Federico Bilotta, Andreas Doronzio, Elisabetta Stazi, Luca Titi, Ivan Orlando Zeppa, Antonella Cianchi, Giovanni Rosa, Francesca Paola Paoloni, Sergio Bergese, Irene Asouhidou, Polimnia Ioannou, Apolonia Elisabeth Abramowicz, Allison Spinelli, Ellise Delphin, Eugenia Ayrian, Vladimir Zelman, Philip Lumb

Primary Institution: Department of Anaesthesiology, Critical Care and Pain Medicine, 'Sapienza' University of Rome, Policlinico Umberto I, Rome, Italy

Hypothesis

Does the type of hypnotic used during general anaesthesia affect the rate of postoperative delirium?

Conclusion

The study aims to determine if different hypnotics used in general anaesthesia lead to varying rates of postoperative delirium.

Supporting Evidence

  • Postoperative delirium can develop in up to 56% of patients, especially the elderly.
  • General anaesthesia is associated with a higher risk of postoperative cognitive dysfunction.
  • Different hypnotics may have varying effects on postoperative cognitive recovery.

Takeaway

This study is trying to find out if the medicine used to put patients to sleep during surgery affects how confused they feel afterward.

Methodology

A multicentre, double-blind, randomized controlled trial comparing desflurane, sevoflurane, and propofol in patients undergoing non-cardiac and non-brain surgeries.

Potential Biases

Potential biases may arise from the subjective assessment of cognitive function and delirium.

Limitations

The study excludes patients undergoing cardiac or brain surgery, which may limit generalizability.

Participant Demographics

Adult patients aged 18 to 75, ASA I-III, without neurological deficits.

Statistical Information

P-Value

0.93

Confidence Interval

null

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/1745-6215-12-170

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