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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.

Li, Ting and Yeung, Joyce and Li, Jun and Zhang, Yan and Melody, Teresa and Gao, Ye and Wang, Yi and Lian, Qianquan and Gao, Fang (2017) 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. BMJ open, 7 (10). e016937. ISSN 2044-6055. This article is available to all HEFT staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their HEFT Athens login IDs

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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.

Item Type: Article
Additional Information: This article is available to all HEFT staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their HEFT Athens login IDs
Subjects: WB Practice of medicine > WB400 Intensive care
WO Surgery > WO500 Anaesthesia
Divisions: Clinical Support > Anaesthetics
Clinical Support > Critical Care
Related URLs:
Depositing User: Mrs Yolande Brookes
Date Deposited: 22 Nov 2017 10:57
Last Modified: 22 Nov 2017 10:57
URI: http://www.repository.heartofengland.nhs.uk/id/eprint/1475

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