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时钟节律对行胸腔镜肺癌手术的老年患者苏醒躁动及术后早期谵妄的影响:一项前瞻性、观察性、队列研究方案。

Effect of clock rhythm on emergence agitation and early postoperative delirium in older adults undergoing thoracoscopic lung cancer surgery: protocol for a prospective, observational, cohort study.

机构信息

Department of Anesthesiology, Zhongshan Hospital, Fudan University, 200032, Shanghai, China.

出版信息

BMC Geriatr. 2024 Mar 12;24(1):251. doi: 10.1186/s12877-024-04846-0.

Abstract

INTRODUCTION

Surgeries conducted at night can impact patients' prognosis, and the mechanism may be related to circadian rhythm, which influence normal physiological functions and pathophysiological changes. Melatonin is primarily a circadian hormone with hypnotic and chronobiotic effects, thereby affecting disease outcomes through influencing the expression of inflammatory factors and biochemical metabolism. This study aims to observe the effects of circadian rhythms on emergence agitation and early postoperative delirium of older individuals undergoing thoracoscopic lung cancer surgery and explore the possible regulatory role of melatonin.

METHODS

This prospective, observational, cohort study will involve 240 patients. Patients will be routinely divided into three groups based on the time of the surgery: T1 (8:00-14:00), T2 (14:00-20:00) and T3 group (20:00-08:00). The primary outcome will be the incidence of emergence agitation assessed via the Richmond Agitation and Sedation Scale (RASS) in the post-anesthesia care unit (PACU). Secondary outcomes will include the incidence of early postoperative delirium assessed via the Confusion Assessment Method (CAM) on postoperative day 1, pain status assessed via the numerical rating scale (NRS) in the PACU, sleep quality on postoperative day 1 and changes in perioperative plasma melatonin, clock genes and inflammatory factor levels. Postoperative surgical complications, intensive care unit admission and hospital length of stay will also be evaluated.

DISCUSSION

This paper describes a protocol for investigating the effects of circadian rhythms on emergence agitation and early postoperative delirium of older individuals undergoing thoracoscopic lung cancer surgery, as well as exploring the potential regulatory role of melatonin. By elucidating the mechanism by which circadian rhythms impact postoperative recovery, we aim to develop a new approach for achieving rapid recovery during perioperative period.

TRIAL REGISTRATION

The study was registered at the Chinese Clinical Trials Registry (ChiCTR2000040252) on November 26, 2020, and refreshed on September 4, 2022.

摘要

简介

夜间进行的手术可能会影响患者的预后,其机制可能与影响正常生理功能和病理生理变化的昼夜节律有关。褪黑素主要是一种昼夜节律激素,具有催眠和时间生物学作用,因此通过影响炎症因子和生化代谢的表达来影响疾病结局。本研究旨在观察昼夜节律对行胸腔镜肺癌手术的老年患者苏醒期躁动和术后早期谵妄的影响,并探讨褪黑素的可能调节作用。

方法

这是一项前瞻性、观察性、队列研究,将纳入 240 例患者。患者将根据手术时间常规分为三组:T1 组(8:00-14:00)、T2 组(14:00-20:00)和 T3 组(20:00-08:00)。主要结局是通过麻醉后恢复室(PACU)中的 Richmond 躁动镇静量表(RASS)评估苏醒期躁动的发生率。次要结局包括术后第 1 天通过意识模糊评估法(CAM)评估的早期术后谵妄发生率、PACU 中的数字评分量表(NRS)评估的疼痛状况、术后第 1 天的睡眠质量以及围手术期血浆褪黑素、时钟基因和炎症因子水平的变化。还将评估术后手术并发症、入住重症监护病房和住院时间。

讨论

本文描述了一项研究方案,旨在研究昼夜节律对行胸腔镜肺癌手术的老年患者苏醒期躁动和术后早期谵妄的影响,并探讨褪黑素的潜在调节作用。通过阐明昼夜节律对术后恢复的影响机制,我们旨在为围手术期快速恢复开发一种新方法。

试验注册

该研究于 2020 年 11 月 26 日在中国临床试验注册中心(ChiCTR2000040252)注册,并于 2022 年 9 月 4 日更新。

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