PDF(Pubmed)
Abstract：
BACKGROUND: Perioperative 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: This 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.
CONCLUSIONS: This 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.
BACKGROUND: Chinese clinical trial registry: ChiCTR2200063488, Registered on 5 October 2022.
METHODS: This 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.
CONCLUSIONS: This 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.
BACKGROUND: Chinese clinical trial registry: ChiCTR2200063488, Registered on 5 October 2022.
摘要：
背景：围手术期睡眠障碍（PSD）是术后谵妄（POD）的独立危险因素，这是手术后常见的并发症。接受机器人辅助前列腺癌根治术（RARP）的老年患者通常会出现围手术期睡眠障碍（PSD）。地塞米松,一种通过抑制下丘脑-垂体-肾上皮质轴起作用的药物，可以减少手术压力的负面影响。这项研究的目的是确定在麻醉诱导时静脉注射地塞米松是否可以改善老年患者术后的睡眠质量。从而间接降低术后认知障碍的风险，加速术后康复。
方法：这项研究是一项随机的，双盲,在单个中心进行的安慰剂对照试验.通过计算确定了116例患者的样本量，这些患者被随机分配到地塞米松组(D组，n=58）或空白对照组（C组，n=58）。手术那天,麻醉护士预先准备了稀释的地塞米松或生理盐水，根据患者的指定组。失明的麻醉师在诱导过程中给药，并由专人对患者进行连续三天的术后随访。两组之间的所有其他护理方面均得到同等管理。主要结果指标是睡眠质量，而次要结局指标包括术后睡眠时间，术后谵妄（POD），疼痛评分,和其他并发症。记录相关的测试措施用于分析。
结论：本研究旨在探讨静脉注射地塞米松对机器人辅助前列腺癌根治术（RARP）患者睡眠质量和持续时间的影响。如果本研究方案的结果是肯定的，能提高老年患者手术后的睡眠质量,从而最大限度地减少术后谵妄（POD）的风险，并为老年患者围手术期加强康复管理提供了大量证据。
背景：中国临床试验注册：ChiCTR2200063488，2022年10月5日注册。
方法：这项研究是一项随机的，双盲,在单个中心进行的安慰剂对照试验.通过计算确定了116例患者的样本量，这些患者被随机分配到地塞米松组(D组，n=58）或空白对照组（C组，n=58）。手术那天,麻醉护士预先准备了稀释的地塞米松或生理盐水，根据患者的指定组。失明的麻醉师在诱导过程中给药，并由专人对患者进行连续三天的术后随访。两组之间的所有其他护理方面均得到同等管理。主要结果指标是睡眠质量，而次要结局指标包括术后睡眠时间，术后谵妄（POD），疼痛评分,和其他并发症。记录相关的测试措施用于分析。
结论：本研究旨在探讨静脉注射地塞米松对机器人辅助前列腺癌根治术（RARP）患者睡眠质量和持续时间的影响。如果本研究方案的结果是肯定的，能提高老年患者手术后的睡眠质量,从而最大限度地减少术后谵妄（POD）的风险，并为老年患者围手术期加强康复管理提供了大量证据。
背景：中国临床试验注册：ChiCTR2200063488，2022年10月5日注册。
