Can dexamethasone improve postoperative sleep and postoperative delirium in elderly patients undergoing robot-assisted laparoscopic radical prostatectomy? Protocol for a prospective, randomized, double-blind, controlled study

Trials

Study Protocol

Jianming Liu¹  Qingyu Sun²  Yi Hua²  Yaping Shi²  Zhou Yi²  Chunting Chen²  Yue Wang²  Jianfei Jin²  Yuting Lu²  Jinjun Bian²  Wei Wang² 

[1] Department of Anesthesiology, School of Medicine, Shanghai Pulmonary Hospital, Tongji University, Shanghai, People’s Republic of China;Department of Anesthesiology, the First Affiliated Hospital of Naval Medical University, Shanghai, People’s Republic of China;

关键词: Dexamethasone;    Robot-assisted radical prostatectomy;    Elderly patient;    Enhanced recovery after surgery;    Postoperative delirium;    Perioperative sleep disorders;   

DOI  :  10.1186/s13063-023-07521-8

 received in 2023-04-26, accepted in 2023-07-17,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundPerioperative sleep disorders (PSD) are an independent risk factor for postoperative delirium (POD), which is a common complication after surgery. Elderly patients who undergo robot-assisted radical prostatectomy (RARP) often experience perioperative sleep disorders (PSD). Dexamethasone, a medication that works by inhibiting the hypothalamic-pituitary-suprarenal cortical axis, can reduce the negative effects of surgical stress. The objective of this study was to determine whether intravenous administration of dexamethasone at the time of anesthesia induction could improve postoperative sleep quality in elderly patients, thereby indirectly reducing the risk of postoperative cognitive impairment and accelerating postoperative rehabilitation.Methods/designThis study is a randomized, double-blind, placebo-controlled trial that was conducted at a single center. A sample size of 116 patients was determined through calculation, and these patients were randomly assigned to either the dexamethasone group (group D, n = 58) or the blank control group (group C, n = 58). On the day of surgery, the anesthesia nurse prepared either diluted dexamethasone or saline in advance, according to the patient's assigned group. The blinded anesthesiologist administered the medication during induction, and a dedicated person followed up with the patient for three consecutive postoperative days. All other aspects of care were managed equally between the two groups. The primary outcome measure was sleep quality, while secondary outcome measures included postoperative sleep time, postoperative delirium (POD), pain scores, and other complications. Relevant test measures were recorded for analysis.DiscussionThis study aims to investigate the impact of intravenous dexamethasone on sleep quality and duration of patients undergoing robot-assisted radical prostatectomy (RARP). If the findings of this study protocol are affirmative, it could enhance the sleep quality of elderly patients after surgery, thereby minimizing the risk of postoperative delirium (POD), and providing substantial evidence for the perioperative enhanced recovery management of elderly patients.Trial registrationChinese clinical trial registry: ChiCTR2200063488, Registered on 5 October 2022.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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