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低剂量氯胺酮用于腹腔镜胆囊切除术的安全性和有效性:一项前瞻性、双盲、随机对照试验。

Safety and efficacy of low-dose esketamine in laparoscopic cholecystectomy: a prospective, double-blind randomized controlled trial.

机构信息

Department of Anesthesiology, The Third Affiliated Hospital of Anhui Medical University, The First People's Hospital of Hefei, Hefei, 230061, Anhui, China.

出版信息

BMC Anesthesiol. 2024 Feb 1;24(1):47. doi: 10.1186/s12871-024-02429-5.

DOI:10.1186/s12871-024-02429-5
PMID:38302944
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10832235/
Abstract

BACKGROUND

Esketamine, recognized for its analgesic, sedative, and anti-inflammatory qualities, is integral in multimodal analgesia. However, the potential opioid-sparing effects of intravenous esketamine, along with its impact on inflammatory responses, and cognitive function during laparoscopic surgery, remain unexplored.

METHODS

In this study, 90 patients scheduled for laparoscopic cholecystectomy were equally randomized into three groups: a normal saline control group (NS), a low-dose esketamine group (LS) and a high-dose esketamine group (HS). Subsequently, we monitored several parameters: hemodynamics, levels of stress and inflammatory responses, intraoperative doses of sufentanil, remifentanil, and propofol, and 24-hour postoperative sufentanil requirements. We also evaluated alterations in cognitive function, perioperative indicators, and potential adverse reactions among the three groups.

RESULTS

Compared to their levels 5 minutes prior to anesthesia (T) and 30 minutes post-operation (T), the NS group exhibited a more significant decrease in Mean Arterial Pressure (MAP) and Heart Rate (HR) at various time intervals: 5 minutes after the skin incision (T), 30 minutes post-incision (T), and at the conclusion of the operation (T), compared to the LS and HS groups(P < 0.05). Furthermore, the NS group exhibited a greater increase in levels of adrenaline (AD), noradrenaline (NE), endothelin (ET), C-reactive protein (CRP), tumor necrosis factor-alpha (TNF-α), and interleukin-6 (IL-6) at T, T, and T, more so than the other two groups(P < 0.05). 24 hours after the surgery, patients in the LS group and HS group had significantly higher Montreal Cognitive Assessment (MoCA) scores than those in the NS group(P < 0.05). The LS and HS groups required lower doses of propofol, remifentanil, and sufentanil during surgery (P < 0.05), experienced shorter postoperative recovery times, and had lower incidences of nausea, vomiting, and respiratory depression compared to the NS group (P < 0.05).

CONCLUSION

The administration of low-dose esketamine has been shown to be safe, effective, and dependable in the context of laparoscopic gallbladder surgery. It has the capacity to stabilize hemodynamic responses, ameliorate both stress and inflammatory reactions from surgery, and hastens anesthesia recovery. Furthermore, it fosters the restoration of postoperative cognitive function. Notably, when combined with nalbuphine, it exhibits opioid-sparing effects, reducing postoperative adverse outcomes.

TRIAL REGISTRATION

The trial is registered with the China Clinical Trials Registry Registration Number: ChiCTR2300067596. Retrospectively registered (date of registration: 12/01/2023).

摘要

背景

埃索美拉唑具有镇痛、镇静和抗炎作用,是多模式镇痛的重要组成部分。然而,静脉注射埃索美拉唑的潜在阿片类药物节约作用,以及其对腹腔镜手术期间炎症反应和认知功能的影响,仍有待探索。

方法

本研究将 90 例行腹腔镜胆囊切除术的患者随机等分为三组:生理盐水对照组(NS)、低剂量埃索美拉唑组(LS)和高剂量埃索美拉唑组(HS)。随后,我们监测了以下参数:血流动力学、应激和炎症反应水平、术中舒芬太尼、瑞芬太尼和丙泊酚的剂量以及术后 24 小时舒芬太尼的需求。我们还评估了三组患者的认知功能改变、围手术期指标和潜在不良反应。

结果

与麻醉前 5 分钟(T)和术后 30 分钟(T)相比,NS 组在皮肤切口后 5 分钟(T)、切口后 30 分钟(T)和手术结束时(T)的平均动脉压(MAP)和心率(HR)明显下降,与 LS 和 HS 组相比(P<0.05)。此外,NS 组在 T、T 和 T 时肾上腺素(AD)、去甲肾上腺素(NE)、内皮素(ET)、C 反应蛋白(CRP)、肿瘤坏死因子-α(TNF-α)和白细胞介素-6(IL-6)水平升高更为明显,与其他两组相比(P<0.05)。术后 24 小时,LS 组和 HS 组患者的蒙特利尔认知评估(MoCA)评分明显高于 NS 组(P<0.05)。LS 组和 HS 组在手术过程中需要更少的丙泊酚、瑞芬太尼和舒芬太尼(P<0.05),术后恢复时间更短,恶心、呕吐和呼吸抑制的发生率低于 NS 组(P<0.05)。

结论

在腹腔镜胆囊手术中,低剂量埃索美拉唑的应用安全、有效且可靠。它能够稳定血流动力学反应,减轻手术引起的应激和炎症反应,加速麻醉恢复。此外,它还能促进术后认知功能的恢复。值得注意的是,当与纳布啡联合使用时,它具有阿片类药物节约作用,减少术后不良结局。

试验注册

该试验在中国临床试验注册中心注册,注册号:ChiCTR2300067596。回顾性注册(注册日期:2023 年 12 月 1 日)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54c3/10832235/290a2ccce264/12871_2024_2429_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54c3/10832235/6e540499a56d/12871_2024_2429_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54c3/10832235/963a0d845fbd/12871_2024_2429_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54c3/10832235/290a2ccce264/12871_2024_2429_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54c3/10832235/6e540499a56d/12871_2024_2429_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54c3/10832235/963a0d845fbd/12871_2024_2429_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54c3/10832235/290a2ccce264/12871_2024_2429_Fig3_HTML.jpg

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