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舒芬太尼与艾司氯胺酮联合静脉给药对心脏手术后疼痛管理及抑郁的有效性:一项随机对照试验

Effectiveness of intravenous administration of a combination of sufentanil and esketamine on post-cardiac surgery pain management and depression: a randomized controlled trial.

作者信息

Xu Sen, Liang Tianyu, Xu Weicai

机构信息

Center for Rehabilitation Medicine Center, Department of Anesthesiology, Zhejiang Provincial People's Hospital (Affiliated People's Hospital, Hangzhou Medical College), Hangzhou, China.

Second Clinical Medical School, Zhejiang Chinese Medical University, Hangzhou, China.

出版信息

Cardiovasc Diagn Ther. 2025 Apr 30;15(2):291-301. doi: 10.21037/cdt-24-312. Epub 2025 Apr 23.

Abstract

BACKGROUND

Cardiac surgery often results in significant postoperative pain, which can lead to complications and prolonged recovery. Pain and depression are closely linked, with effective pain management potentially reducing the risk of depression. Combining sufentanil, an opioid, with esketamine, a medication with both analgesic and antidepressant effects, may improve pain control and mood in postoperative patients. While promising in other surgeries, their effects in cardiac surgery remain unclear. This study explores how sufentanil and esketamine work together to manage pain and reduce depression after cardiac surgery.

METHODS

A randomized controlled clinical trial was conducted from January 2021 to December 2023, involving 104 patients who underwent cardiac surgery. Patients [aged 61-64 years, body mass index (BMI) <30 kg/m, American Society of Anesthesiologists (ASA) I-II, the snoring, tiredness, observed apnea, high blood pressure, body mass index, age, neck circumference, and male gender (STOP-Bang) score <3] were randomly assigned to a control group (n=52) receiving 2.5 µg/kg sufentanil or an experimental group (n=52) receiving 2.0 µg/kg sufentanil with 2 mg/kg esketamine via a central venous catheter for 48 h postoperatively. Exclusion criteria included allergies to fentanyl or etomidate, central nervous system diseases, recent opioid use, liver/kidney failure, or severe respiratory conditions. Outcome measures included patient-controlled intravenous analgesia (PCIA) pump usage, pain scores, clinical indicators, depressive symptoms, adverse events, and satisfaction levels.

RESULTS

The experimental group had significantly fewer PCIA pump button presses (2.41±0.72) than the control group (6.20±1.31) (P<0.001). Visual analog pain scores were lower in the experimental group at multiple postoperative time points (P<0.05). Hamilton Depression Rating Scale (HAMD) scores were significantly lower in the experimental group (7.52±4.24) compared to the control group (13.84±2.76) (P<0.05), as were Hamilton Anxiety Rating Scale (HAMA) scores (8.84±2.13 12.64±3.25, P<0.05). Heart rate and mean arterial pressure were higher at postoperative time points T2, T3, and T4 in the experimental group (P<0.05), but no difference was observed at T1 (P>0.05) (T1 =4 h, T2 =8 h, T3 =24 h, T4 =48 h post-surgery). Oxygen saturation showed no significant difference between groups (P>0.05). Adverse reactions occurred in 13.46% of the experimental group and 19.23% of the control group, with no statistically significant difference (P>0.05). Patient and surgeon satisfaction scores were uniformly high on a five-point scale (both groups had median =5).

CONCLUSIONS

The combined administration of sufentanil and esketamine effectively managed pain and significantly reduced depressive symptoms in post-cardiac surgery patients. The experimental group demonstrated reduced PCIA usage and improved clinical indicators. These findings provide valuable insights for enhancing postoperative recovery and addressing both pain management and psychological well-being.

TRIAL REGISTRATION

Chinese Clinical Trial Registry; identifier: ChiCTR2400092428.

摘要

背景

心脏手术通常会导致显著的术后疼痛,这可能会引发并发症并延长恢复时间。疼痛与抑郁密切相关,有效的疼痛管理可能会降低抑郁风险。将阿片类药物舒芬太尼与具有镇痛和抗抑郁作用的药物艾司氯胺酮联合使用,可能会改善术后患者的疼痛控制和情绪。虽然在其他手术中前景良好,但其在心脏手术中的效果仍不明确。本研究探讨舒芬太尼和艾司氯胺酮如何协同作用来管理心脏手术后的疼痛并减轻抑郁。

方法

于2021年1月至2023年12月进行了一项随机对照临床试验,纳入104例行心脏手术的患者。患者[年龄61 - 64岁,体重指数(BMI)<30 kg/m²,美国麻醉医师协会(ASA)分级I - II级,鼾症、疲劳、观察到的呼吸暂停、高血压、体重指数、年龄、颈围及男性性别(STOP - Bang)评分<3分]被随机分为对照组(n = 52),接受2.5 μg/kg舒芬太尼,或试验组(n = 52),接受2.0 μg/kg舒芬太尼与2 mg/kg艾司氯胺酮,通过中心静脉导管术后持续输注48小时。排除标准包括对芬太尼或依托咪酯过敏、中枢神经系统疾病、近期使用阿片类药物、肝/肾功能衰竭或严重呼吸系统疾病。观察指标包括患者自控静脉镇痛(PCIA)泵使用情况、疼痛评分、临床指标、抑郁症状、不良事件及满意度。

结果

试验组PCIA泵按压次数(2.41±0.72)显著少于对照组(6.20±1.31)(P<0.001)。试验组在多个术后时间点的视觉模拟疼痛评分较低(P<0.05)。试验组汉密尔顿抑郁量表(HAMD)评分(7.52±4.24)显著低于对照组(13.84±2.76)(P<0.05),汉密尔顿焦虑量表(HAMA)评分也是如此(8.84±2.13对12.64±3.25,P<0.05)。试验组术后T2、T3和T4时间点的心率和平均动脉压较高(P<0.05),但T1时间点无差异(P>0.05)(T1 =术后4小时,T2 =术后8小时,T3 =术后24小时,T4 =术后48小时)。两组间血氧饱和度无显著差异(P>0.05)。试验组不良反应发生率为13.46%,对照组为19.23%,差异无统计学意义(P>0.05)。患者和外科医生的满意度评分在五分制中均较高(两组中位数均 = 5)。

结论

舒芬太尼和艾司氯胺酮联合给药有效地控制了心脏手术后患者的疼痛,并显著减轻了抑郁症状。试验组PCIA使用减少,临床指标改善。这些发现为促进术后恢复以及解决疼痛管理和心理健康问题提供了有价值的见解。

试验注册

中国临床试验注册中心;标识符:ChiCTR2400092428。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f804/12082191/f97ad8705e8c/cdt-15-02-291-f1.jpg

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