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昂丹司琼预防有无术前焦虑的无痛取卵患者术后恶心呕吐的比较:一项前瞻性、随机、对照试验。

A comparison of ondansetron in preventing postoperative nausea and vomiting for patients with or without preoperative anxiety with painless egg retrieval: a prospective, randomized, controlled trial.

作者信息

Mou Ying, Zhao Wei, Pan Weizhou, Li Xinnan, Sun Manyun, Bo Yun, Zhao Yanhua, Hu Yaoshen, Peng Jun, Deana Cristian, Kaserer Alexander, Ishii Koji, Yang Liu, Jin Hua

机构信息

Department of Anesthesiology, The First People's Hospital of Yunnan Province, Kunming, China.

Department of Anesthesiology, The People's Hospital of Guandu District, Kunming, China.

出版信息

Gland Surg. 2024 Aug 31;13(8):1522-1534. doi: 10.21037/gs-24-175. Epub 2024 Aug 12.

DOI:10.21037/gs-24-175
PMID:39282027
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11399016/
Abstract

BACKGROUND

Patients undergoing painless egg retrieval are prone to preoperative anxiety, and whether preoperative anxiety induces postoperative nausea and vomiting (PONV) is debated. The primary objective of this prospective, randomized, controlled study was to compare the clinical effect of ondansetron in preventing PONV for patients with and without preoperative anxiety. The secondary objective was to investigate whether preoperative anxiety was associated with PONV.

METHODS

The self-rating anxiety scale (SAS) was used to assess the anxiety patients undergoing painless egg retrieval. Patients with a SAS standard score of 50-60 were selected to the anxiety group (n=105); and patients with a SAS standard score of 25-35 were assigned to the non-anxiety group (n=104). Venous blood samples of both groups of patients were obtained during admission and 1 hour after surgery, and all serotonin (5-HT) levels were tested using an enzyme-linked immunosorbent assay. The anxiety group was then randomly assigned into two subgroups: ondansetron (AO group, n=53) and placebo saline (AS group, n=52). Similarly, patients in the non-anxiety group were also randomly assigned to one of two subgroups: ondansetron (NO group, n=51) and placebo saline (NS group, n=53). The AO and NO groups received 8 mg (4 mL) of intravenous ondansetron 15 minutes before surgery, while the AS and NS groups received an equivalent volume (4 mL) of normal saline. We then analyzed the vital signs, risk factors for nausea and vomiting, intraoperative anesthetic doses, incidences of nausea and vomiting in 24 hours after surgery, serum 5-HT level before and after surgery, other adverse responses, pain scores, and satisfaction.

RESULTS

A total of 200 patients eventually completed this study. The serum 5-HT values in the anxiety group were higher before and after surgery than in the non-anxiety group (P<0.05), but there was no significant difference in serum 5-HT before and after surgery in the same group (P>0.05). The incidence of PONV was more significant in the AS group than in the NS group (P<0.05). The incidence of PONV was also higher in the AS group than in the AO group (P<0.05). Still, there was no statistically significant difference between the NO and NS groups (P>0.05). There were no significant differences between the four groups in vital signs, risk factors for nausea and vomiting, intraoperative anesthetic doses, other adverse responses and pain scores (P>0.05). Patients in the AS group had lower satisfaction scores than those in the other three groups (P<0.05).

CONCLUSIONS

Patients experiencing preoperative anxiety have a greater risk of PONV following painless egg retrieval compared to those without preoperative anxiety. Ondansetron can reduce the occurrence of PONV in patients with preoperative anxiety, but it has no discernible preventative effect in non-anxious patients.

TRIAL REGISTRATION

Chinese Clinical Trial Registry ChiCTR2400079504.

摘要

背景

接受无痛取卵手术的患者术前易出现焦虑情绪,术前焦虑是否会诱发术后恶心呕吐(PONV)存在争议。这项前瞻性、随机、对照研究的主要目的是比较昂丹司琼对有或无术前焦虑的患者预防PONV的临床效果。次要目的是调查术前焦虑是否与PONV相关。

方法

采用自评焦虑量表(SAS)评估接受无痛取卵手术患者的焦虑情况。将SAS标准评分50 - 60分的患者纳入焦虑组(n = 105);SAS标准评分25 - 35分的患者分配至非焦虑组(n = 104)。两组患者入院时及术后1小时采集静脉血样,采用酶联免疫吸附测定法检测所有血清5 - 羟色胺(5 - HT)水平。然后将焦虑组随机分为两个亚组:昂丹司琼组(AO组,n = 53)和安慰剂生理盐水组(AS组,n = 52)。同样,非焦虑组患者也随机分为两个亚组之一:昂丹司琼组(NO组,n = 51)和安慰剂生理盐水组(NS组,n = 53)。AO组和NO组在手术前15分钟静脉注射8 mg(4 mL)昂丹司琼,而AS组和NS组给予等量体积(4 mL)的生理盐水。然后我们分析生命体征、恶心呕吐的危险因素、术中麻醉剂量、术后24小时内恶心呕吐的发生率、手术前后血清5 - HT水平、其他不良反应、疼痛评分和满意度。

结果

共有200例患者最终完成本研究。焦虑组手术前后血清5 - HT值均高于非焦虑组(P < 0.05),但同一组手术前后血清5 - HT无显著差异(P > 0.05)。AS组PONV发生率高于NS组(P < 0.05)。AS组PONV发生率也高于AO组(P < 0.05)。然而,NO组和NS组之间无统计学显著差异(P > 0.05)。四组在生命体征、恶心呕吐的危险因素、术中麻醉剂量、其他不良反应和疼痛评分方面无显著差异(P > 0.05)。AS组患者的满意度评分低于其他三组(P < 0.05)。

结论

与无术前焦虑的患者相比,术前焦虑的患者在无痛取卵术后发生PONV的风险更高。昂丹司琼可降低术前焦虑患者PONV的发生,但对非焦虑患者无明显预防作用。

试验注册

中国临床试验注册中心ChiCTR2400079504

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