Effect of stellate ganglion block on delirium after major surgery in elderly patients: protocol for a randomised controlled study.

INTRODUCTION

Postoperative delirium (POD) remains a prevalent neurological complication among elderly patients following major surgeries, with limited effective preventive measures currently available. Stellate ganglion block (SGB) is widely employed in clinical practices to manage various conditions by modulating the sympathetic nervous system activity. However, there is currently a lack of clinical evidence assessing its effect on the incidence of POD. This study aims to evaluate the safety and efficacy of SGB as a preventive strategy for POD in elderly patients undergoing major surgeries.

METHODS AND ANALYSIS

This randomised controlled clinical trial will be conducted at two centres, enrolling a total of 300 elderly patients aged 65 years and older who are scheduled for elective major surgery. Participants will be randomly assigned to either the SGB group (n=150) or the control group (n=150). In the SGB group, participants will receive an ultrasound-guided SGB using 7 mL of local anaesthetic, while the control group will receive 2 mL of saline injected into the muscle tissue on the anterolateral side of the SG. The primary outcome will be the occurrence of POD within 7 days postsurgery or before discharge. POD will be assessed two times per day using either the confusion assessment method (CAM) or the CAM for the intensive care unit. Secondary outcomes will include the severity of POD, postsurgical sleep quality, overall recovery quality and the incidence of adverse events.

ETHICS AND DISSEMINATION

The trial protocol has been approved by the Ethics Committees of the Affiliated Hospital of Jiaxing University (approval number 2023-KY-479) and Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (approval number 2023-0747). Written informed consent will be obtained from all participants prior to study inclusion. Data collected will be disseminated at scientific conferences and published in peer-reviewed journals.

TRIAL REGISTRATION NUMBER

ChiCTR 2300077883.