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老年患者长期全身麻醉术后谵妄,如何降低其发生率?:一项双盲、随机、安慰剂对照试验方案。

Postoperative delirium after long-term general anesthesia in elderly patients, how to reduce it?: Protocol of a double-blinded, randomized, placebo-controlled trial.

机构信息

Chongqing Shapingba District People's Hospital.

Xinqiao Community Health Service Center, Shapingba District, Chongqing, China.

出版信息

Medicine (Baltimore). 2021 Jun 4;100(22):e25885. doi: 10.1097/MD.0000000000025885.

Abstract

BACKGROUND

Long operation duration (>4 hours' anesthesia) of laparotomy in elderly patients would increase the risk of postoperative delirium (POD), which is characterized by acute cognitive dysfunction, changes in the level of consciousness, obvious attention disorder, emotional disorder, and sleep-waking cycle disorder. The occurrence of POD is closely related to the risk of death, and it will also seriously affect the cognitive function of patients, prolong postoperative hospital stays, and increase medical expenses. It is known that dexmetomidine could function in sedation, analgesia and anti-sympathetic effect, and it also could simulate the normal sleep state of human body, but there is still a lack of clinical study of dexmedetomidine on the incidence of POD in elderly patients undergoing long-term general anesthesia in laparotomy.

METHODS

This is a single-center, double-blinded, randomized controlled study. With the approval of the Ethics Committee of Chongqing Shapingba District People's Hospital, participants who meet the requirements will be randomly divided into the treatment group (continuous infusion of dexmetomidine) and the control group (continuous infusion of 0.9% sodium chloride solution) in a ratio of 1:1. The incidence of delirium, cognitive function score, inflammatory factors, and adverse reactions will be evaluated after the operation. Finally, the data will be analyzed by SPSS 22.0.

CONCLUSION

The results of this study will explore the efficacy and safety of dexmetomidine in reducing the incidence of postoperative delirium in elderly patients undergoing long-term general anesthesia in laparotomy.

TRIAL REGISTRATION

OSF Registration number: DOI 10.17605/OSF.IO/2GJY6.

摘要

背景

老年患者剖腹手术的麻醉时间(>4 小时)较长,会增加术后谵妄(POD)的风险,其特征为急性认知功能障碍、意识水平改变、明显的注意力障碍、情绪障碍和睡眠-觉醒周期障碍。POD 的发生与死亡风险密切相关,也会严重影响患者的认知功能,延长术后住院时间,增加医疗费用。已知右美托咪定具有镇静、镇痛和抗交感作用,还可以模拟人体的正常睡眠状态,但对于接受长时间全麻的老年患者,右美托咪定对 POD 发生率的影响仍缺乏临床研究。

方法

这是一项单中心、双盲、随机对照研究。经重庆沙坪坝区人民医院伦理委员会批准,符合要求的参与者将以 1:1 的比例随机分为治疗组(连续输注右美托咪定)和对照组(连续输注 0.9%氯化钠溶液)。术后评估谵妄发生率、认知功能评分、炎症因子和不良反应。最后,采用 SPSS 22.0 对数据进行分析。

结论

该研究的结果将探讨右美托咪定在降低接受长时间全麻的老年患者剖腹手术术后谵妄发生率方面的疗效和安全性。

试验注册

OSF 注册号:DOI 10.17605/OSF.IO/2GJY6。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/48a6/8183711/60e442f1123c/medi-100-e25885-g001.jpg

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