Xenon - Post Operative Delirium

• Research type

  Research Study

• Full title

  An international, multi-centre, randomized, controlled trial evaluating the effect of xenon on post-operative delirium in elderly patients undergoing hip fracture surgery.

• IRAS ID

  39574

• Contact name

  Patrick Doyle

• Sponsor organisation

  Air Liquide Sante International

• Eudract number

  2009-017153-35

• ISRCTN Number

  Not Sent

• Research summary

  This is a Phase II, randomised, blind, parallel group controlled trial to evaluate the effect of Xenon an anaesthetic on Post-Operative Delirium (POD) in elderly patients undergoing hip fracture surgery. POD is an acute change in cognitive status characterised by fluctuating consciousness and inattention within 30 days after an operation and occurs in 15 - 53 per cent of older patients. The development of which often initiates a cascade of events culminating in the loss of independence, poor functional recovery, increase in length of hospital stay, morbidity and mortality and health care costs. Eligible patients of 75 years and above with planned hip fracture surgery within 48 hours after hip fracture, meeting none of the exclusion criteria will be randomly assigned to one of two treatment groups. Group A patients will receive Xenon during anaesthesia and Group B patients will receive Sefluane. The following verbal questionnaires and doctor assessments; Confusion Assessment Method (CAM), Sequential Organ Failure Assessment (SOFA), Mini-mental State Examination (MMSE), Post-operative Nausea and Vomiting (PONV) verbal rating scale and Aldrete score will be used post-surgery until patient discharge from hospital to evaluate the incidence of POD compared between the two treatment groups. In addition the time of first POD diagnosis, duration of POD, physiological status of the patient pre- and post-surgery, recovery parameters and economical impact of POD in the post-operative period will also be evaluated. The working hypotheses of this trial are that Xeon may contribute to a lower incidence of POD as compared to Sevolfurane, may contribute to reduce post-operative organs dysfunction and may reduce healthcare costs associated with POD.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  10/H0713/35

• Date of REC Opinion

  6 Jul 2010

• REC opinion

  Further Information Favourable Opinion