The Comparison of the Efficacy of Esketamine Over Sufentanil to Reduce Postoperative Nausea and Vomiting in Gynecological Laparoscopic Surgery: A Prospective, Double-Blind, Randomized Controlled Trial.

IF 5.1 2区医学 Q1 CHEMISTRY, MEDICINAL

Drug Design, Development and Therapy Pub Date : 2025-10-02 eCollection Date: 2025-01-01 DOI:10.2147/DDDT.S533198

Zhuolin Qiu, Yue Guo, Weilong Zhong, Weiqiang Chen, Ping Xiang, Jianfen Liang, Jingyi Du, Xiang Li

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Abstract

Background: Postoperative nausea and vomiting (PONV) affect 40-80% of patients undergoing gynecological laparoscopy (GLS). Opioids, though effective for analgesia, may exacerbate PONV. Esketamine, the dextrorotatory form of ketamine with analgesic, sedation and anti-inflammatory properties, was evaluated for PONV prophylaxis compared to sufentanil.

Methods: In this single-center, double-blind trial, 150 patients undergoing elective GLS were randomized to receive esketamine (0.25mg/kg, n=75) or sufentanil (0.1μg/kg, n=75) at the incision closing. Primary outcomes were PONV incidence and severity in Postanesthesia care unit (PACU) and during 48 hours postoperation. Secondary outcomes included pain scores, supplemental analgesia use, sore throat and bucking at excubation. Statistical analyses utilized t-tests, Mann-Whitney U, and χ²-tests (significance: p < 0.05) with Friedman test for within-group comparisons and generalized estimating equations (GEE) for group-time interaction evaluation.

Results: The esketamine group demonstrated significantly lower PONV incidence (in PACU: 57.3% vs 36%, p=0.014; 24h: 53.3% vs 36%, p=0.048) and reduced severity within 24 hours (in PACU, p<0.001; 6h, P=0.042; 24h, p=0.029). Secondary outcomes favored esketamine: lower dynamic pain scores during coughing (in PACU, p=0.017; 6h, P=0.021; 24h, p=0.012), lower severity of sore throat (6h, P=0.019; 24h, p=0.028), reduced rescue analgesia needs (6h: RD=0.12, p=0.037), and decreased incidence of bucking reflex (RD=0.21, p=0.014).

Conclusion: Single-dose esketamine significantly reduces PONV incidence and severity in GLS, improves dynamic analgesia, and mitigates extubation complications. These results support the single dose use of esketamine as an opioid-sparing adjunct to prevent PONV in gynecological laparoscopy.

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艾氯胺酮与舒芬太尼减少妇科腹腔镜手术术后恶心呕吐的疗效比较：一项前瞻性、双盲、随机对照试验。

背景：40-80%的妇科腹腔镜手术（GLS）患者发生术后恶心呕吐（PONV）。阿片类药物虽然对镇痛有效，但可能加重PONV。艾氯胺酮是氯胺酮的右旋形式，具有镇痛、镇静和抗炎特性，与舒芬太尼相比，对其预防PONV的效果进行了评估。方法：在本单中心双盲试验中，150例选择性GLS患者随机接受艾氯胺酮（0.25mg/kg, n=75）或舒芬太尼（0.1μg/kg, n=75）闭合切口。主要结局是麻醉后护理单位（PACU）和术后48小时内PONV的发生率和严重程度。次要结局包括疼痛评分、补充镇痛药的使用、喉咙痛和拔管时的屈曲。统计分析采用t检验、Mann-Whitney U检验和χ 2检验（显著性：p < 0.05），组内比较采用Friedman检验，组间相互作用评价采用广义估计方程（GEE）。结果：艾氯胺酮组PONV发生率显著降低（PACU组：57.3% vs 36%, p=0.014； 24h组：53.3% vs 36%, p=0.048）， 24h内严重程度显著降低（PACU组，p=0.048）。结论：单剂量艾氯胺酮可显著降低GLS组PONV发生率和严重程度，改善动态镇痛，减轻拔管并发症。这些结果支持单剂量使用艾氯胺酮作为一种节省阿片类药物的辅助药物来预防妇科腹腔镜下的PONV。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drug Design, Development and Therapy CHEMISTRY, MEDICINAL-PHARMACOLOGY & PHARMACY

CiteScore

9.00

自引率

0.00%

发文量

382

审稿时长

>12 weeks

期刊介绍： Drug Design, Development and Therapy is an international, peer-reviewed, open access journal that spans the spectrum of drug design, discovery and development through to clinical applications. The journal is characterized by the rapid reporting of high-quality original research, reviews, expert opinions, commentary and clinical studies in all therapeutic areas. Specific topics covered by the journal include: Drug target identification and validation Phenotypic screening and target deconvolution Biochemical analyses of drug targets and their pathways New methods or relevant applications in molecular/drug design and computer-aided drug discovery* Design, synthesis, and biological evaluation of novel biologically active compounds (including diagnostics or chemical probes) Structural or molecular biological studies elucidating molecular recognition processes Fragment-based drug discovery Pharmaceutical/red biotechnology Isolation, structural characterization, (bio)synthesis, bioengineering and pharmacological evaluation of natural products** Distribution, pharmacokinetics and metabolic transformations of drugs or biologically active compounds in drug development Drug delivery and formulation (design and characterization of dosage forms, release mechanisms and in vivo testing) Preclinical development studies Translational animal models Mechanisms of action and signalling pathways Toxicology Gene therapy, cell therapy and immunotherapy Personalized medicine and pharmacogenomics Clinical drug evaluation Patient safety and sustained use of medicines.