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Comparison of regional with general anaesthesia on postoperative delirium (RAGA-delirium) in the older patients undergoing hip fracture surgery: study protocol for a multicentre randomised controlled trial
  1. Ting Li1,
  2. Joyce Yeung2,3,
  3. Jun Li1,
  4. Yan Zhang4,
  5. Teresa Melody3,
  6. Ye Gao1,
  7. Yi Wang1,
  8. Qianquan Lian1,
  9. Fang Gao1,2
  10. on behalf of the RAGA-Delirium Investigators
  1. 1 Department of Anesthesia, The Second Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
  2. 2 Perioperative, Critical Care and Trauma Trials Group, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
  3. 3 Academic Department of Anaesthesia, Critical Care, Pain and Resuscitation, Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust, Birmingham, UK
  4. 4 Key Lab. of Reproduction Regulation of NPFPC, SIPPR, IRD, Fudan University, Shanghai, China
  1. Correspondence to Professor Fang Gao; f.g.smith{at}bham.ac.uk

Abstract

Introduction Postoperative delirium (POD) is a common serious postoperative complication especially in older people and is associated with increased mortality, morbidity and healthcare costs. There is no clear consensus which anaesthesia is associated with less incidence of POD for older patients. We aim to assess whether regional anaesthesia results in lower incidence of POD comparing with general anaesthesia (GA) among older patients undergoing hip fracture surgery.

Methods and analysis RAGA-delirium is a pragmatic, multicentre, prospective, parallel grouped, randomised controlled clinical trial comparing RA or GA for hip fracture surgery. A total of 1000 patients who are 65 years or over and who are having planned hip fracture surgery in nine clinical trial centres of China will be randomised in a 1:1 ratio to receive either anaesthesia for the surgery. The primary endpoint will be the incidence of POD at day 7. The secondary endpoints will be the subtype, severity and duration of delirium, postoperative acute pain score, incidence of other postoperative non-delirium complications, quality of life and cost-effective outcomes. Randomisation will be performed at the patient level using computer-generated assignment. Outcome assessors will be blinded from intervention assignment. Assessments will be conducted before surgery, intraoperatively, postoperatively, during the hospital stay, at 30-day, 6-month and 1-year postoperative intervals.

Potential impact of study This study will provide clinical evidence with a more robust methodology to help anaesthetists in selecting appropriate anaesthesia for older patients with high risk for POD. At the era of increasing emphasis on delirium prevention, this trial has the potential to inform the future national guideline to reduce POD.

Ethics and dissemination Ethical approved by the local institutional review board. Trial results will be presented at national and international academic conferences, and published in peer-reviewed journals.

Trial registration number ClinicalTrials.gov (NCT02213380); pre-results.

  • hip fracture

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Footnotes

  • Contributors All authors have made substantial contributions to the conception or design of the work, or the acquisition, analysis or interpretation of data. TL and YZ drafted the manuscript. JY, JL, YG, TM, YW, QL and FG revised it critically for important intellectual content. TM edited the language. All authors approved final version and agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

  • Funding This work was funded by Zhejiang Health and Family Planning Commission Programme and the Recruitment Program of Global Experts (Grant number: 2014PYA015), China.

  • Competing interests None declared.

  • Patient consent Obtained.

  • Ethics approval The study has been approved by the IRB of The Second Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University and by the local IRB of the participating centres.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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