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丙泊酚与右美托咪定用于接受内镜逆行胰胆管造影术的癌症患者镇静的随机单盲对照研究。

Propofol versus Dexmedetomidine for Sedation of Cancer Patients Undergoing Endoscopic Retrograde Cholangiopancreatography: Randomized Single-Blinded Controlled Study.

作者信息

Soliman Ahmed Mohamed, Hamad Yehya Mohamed, Almaghraby Abeer AbdElmonem, Mohamed Ahmed Abdalla, Abdallah Shady Rady

机构信息

Anaesthesia, ICU and Pain Management Department, National Cancer Institute, Cairo University, Giza, Egypt.

Anaesthesia, ICU and Pain Management Department, Faculty of Medicine, Cairo University, Giza, Egypt.

出版信息

Anesth Pain Med. 2024 Sep 9;14(4):e148512. doi: 10.5812/aapm-148512. eCollection 2024 Aug.

Abstract

BACKGROUND

Endoscopic retrograde cholangiopancreatography (ERCP) is a primary diagnostic and therapeutic option for pancreaticobiliary pathologies.

OBJECTIVES

This study aimed to investigate the efficacy and safety of dexmedetomidine versus propofol during ERCP in cancer patients.

METHODS

This randomized controlled single-blinded trial was conducted with 202 cancer patients aged 21 to 60 years, of both sexes, with a body mass index of 18.5 to 30 kg/m, and classified as American Society of Anesthesiologists (ASA) class II - III, who were undergoing ERCP. The patients were randomly assigned to two equal groups. The Propofol Group (n = 101) received a loading dose of propofol (1 - 2 mg/kg over 30 seconds) followed by an infusion (0.05 - 0.1 mg/kg/hour). The Dexmedetomidine Group (n = 101) received a loading dose of dexmedetomidine (1 μg/kg over 10 minutes) followed by an infusion (0.2 - 0.7 μg/kg/hour). The maintenance dose was adjusted during the procedure based on vital signs, Bispectral Index (BIS), and oxygen saturation.

RESULTS

The Dexmedetomidine group showed a significantly lower incidence of intra-procedural hypoxemic events (14.9% vs. 26.7%, P = 0.037) and a comparable incidence of hypotension (17.8% vs. 13.9%, P = 0.441). Dexmedetomidine also demonstrated significantly lower intraoperative pain scores according to the Facial Pain Score (P < 0.05), significantly lower postoperative Visual Analog Scale (VAS) scores (P < 0.05), and a lower frequency of postoperative nausea and vomiting (PONV) compared to the Propofol group. Additionally, there was a significantly higher frequency of endoscopist satisfaction in the Dexmedetomidine group compared to the Propofol group (P < 0.05).

CONCLUSIONS

Dexmedetomidine can be used as a safe and effective alternative to propofol for deep sedation of cancer patients undergoing ERCP. It is associated with a lower incidence of hypoxemic events, effective intraoperative sedation, quicker recovery, and superior analgesic effects both intraoperatively and postoperatively compared to propofol.

摘要

背景

内镜逆行胰胆管造影术(ERCP)是胰腺胆管疾病的主要诊断和治疗方法。

目的

本研究旨在探讨右美托咪定与丙泊酚在癌症患者ERCP术中的有效性和安全性。

方法

本随机对照单盲试验纳入了202例年龄在21至60岁之间、体重指数为18.5至30kg/m²、性别不限、美国麻醉医师协会(ASA)分级为II - III级且正在接受ERCP的癌症患者。患者被随机分为两组,每组人数相等。丙泊酚组(n = 101)给予负荷剂量的丙泊酚(30秒内1 - 2mg/kg),随后进行输注(0.05 - 0.1mg/kg/小时)。右美托咪定组(n = 101)给予负荷剂量的右美托咪定(10分钟内1μg/kg),随后进行输注(0.2 - 0.7μg/kg/小时)。在手术过程中,根据生命体征、脑电双频指数(BIS)和血氧饱和度调整维持剂量。

结果

右美托咪定组术中低氧血症事件的发生率显著低于丙泊酚组(14.9%对26.7%,P = 0.037),低血压发生率相当(17.8%对13.9%,P = 0.441)。根据面部疼痛评分,右美托咪定组术中疼痛评分也显著更低(P < 0.05),术后视觉模拟评分(VAS)显著更低(P < 0.05),且术后恶心呕吐(PONV)的发生率低于丙泊酚组。此外,与丙泊酚组相比,右美托咪定组内镜医师满意度更高(P < 0.05)。

结论

右美托咪定可作为丙泊酚的安全有效替代药物,用于癌症患者ERCP术的深度镇静。与丙泊酚相比,它与更低的低氧血症事件发生率、有效的术中镇静、更快的恢复以及术中及术后更好的镇痛效果相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/18ab/11895786/5ebf713f529b/aapm-14-4-148512-i001.jpg

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