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

Oct 25, 2017BMJ open

Regional versus general anesthesia and their effects on confusion after hip fracture surgery in older patients

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Abstract

A total of 1000 patients aged 65 years or older will be randomized to compare regional anaesthesia and general anaesthesia for hip fracture surgery.

Postoperative delirium (POD) is a significant complication in older patients, linked to increased mortality and healthcare costs.
There is currently no consensus on whether regional anaesthesia or general anaesthesia leads to a lower incidence of POD in this population.
The primary outcome of the trial will measure the incidence of POD at day 7 post-surgery.
Secondary outcomes include the subtype, severity, and duration of delirium, as well as postoperative pain scores and quality of life.
Outcome assessors will remain blinded to the anaesthesia type assigned to each patient.

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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.

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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

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