Effects of two different anesthesia-analgesia methods on incidence of postoperative delirium in elderly patients undergoing major thoracic and abdominal surgery: study rationale and protocol for a multicenter randomized controlled trial.

Ya-Wei Li,Dong-Xin Wang,Huai-Jin Li,Ming-Zhang Zuo,Xiao-Yun Hu,Bin-Jiang Zhao,Hui-Juan Li,Hong-Ye Zhang,Yi Feng,Xiang-Yang Guo,Yao Yu,Mei-Rong Wang,Ping Ji,Yan Li,Yang-Feng Wu,Xiao-Yan Yan

doi:10.1186/s12871-015-0118-5

Abstract

BackgroundDelirium is a common complication in elderly patients after surgery and associated with increased morbidity and mortality. Studies suggest that deep anesthesia and intense pain are important precipitating factors of postoperative delirium. Neuraxial block is frequently used in combination with general anesthesia for patients undergoing major thoracic and abdominal surgery. Compared with general anesthesia alone and postoperative intravenous analgesia, combined epidural-general anesthesia and postoperative epidural analgesia decreases the requirement of general anesthetics during surgery and provided better pain relief after surgery. However, whether combined epidural-general anesthesia plus epidural analgesia is superior to general anesthesia plus intravenous analgesia in decreasing the incidence of postoperative delirium remains unknown.Methods/designThis is a multicenter, open-label, randomized, parallel-controlled clinical trial. One thousand eight hundred elderly patients (age range 60–90 years) who are scheduled to undergo major thoracic or abdominal surgery are randomized to receive either general anesthesia plus postoperative intravenous analgesia or combined epidural-general anesthesia plus postoperative epidural analgesia. The primary outcome is the 7-day incidence of postoperative delirium. Secondary outcomes include the duration of postoperative delirium, the intensity of pain during the first three days after surgery, the 30-day incidences of postoperative non-delirium complications, the length of stay in hospital after surgery and 30-day all-cause mortality.DiscussionResults of the present study will provide information to guide clinical practice in choosing appropriate anesthesia-analgesia method for elderly patients undergoing major thoracic and abdominal surgery.Trial registrationThe study is registered on ClinicalTrials.gov NCT01661907 and Chinese Clinical Trial Registry ChiCTR-TRC-12002371.

Highlights

Delirium is a common complication in elderly patients after surgery and associated with increased morbidity and mortality
The purpose of this study is to investigate whether two different anesthesia-analgesia methods would lead to a difference in the incidence of postoperative delirium in elderly patients after major thoracic and abdominal surgery
They are trained by a psychiatrist to assess delirium with the Confusion Assessment Method for the Intensive Care Unit (CAM-intensive care unit (ICU)) which is performed in two steps [43, 44]

Summary

Introduction

Delirium is a common complication in elderly patients after surgery and associated with increased morbidity and mortality. Compared with general anesthesia alone and postoperative intravenous analgesia, combined epidural-general anesthesia and postoperative epidural analgesia decreases the requirement of general anesthetics during surgery and provided better pain relief after surgery. Whether combined epidural-general anesthesia plus epidural analgesia is superior to general anesthesia plus intravenous analgesia in decreasing the incidence of postoperative delirium remains unknown. The occurrence of postoperative delirium is associated with worse outcomes, including prolonged length of stay in the ICU and hospital, increased morbidity and mortality, compromised long-term cognitive function and physical ability, and elevated medical care costs [6,7,8,9,10,11,12,13,14,15]. Strategies that can effectively prevent the occurrence of postoperative delirium are limited [16, 17]

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