Use of a Combination Lavender/Peppermint Aromatherapy Patch During Port Catheter Placement Under Monitored Anesthesia Care Does Not Reduce Time to Discharge Readiness: A Randomized Controlled Trial.

IF 1.3 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Journal of Integrative and Complementary Medicine Pub Date : 2024-09-01 Epub Date: 2024-03-19 DOI:10.1089/jicm.2023.0416
Neil Bailard, Daniel S Cukierman, Juan J Guerra-Londono, Ervin Brown, Carin Hagberg, Andrea Sauer, Juan P Cata
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Abstract

Background: Intraoperative anxiety is a common problem when Monitored Anesthesia Care (MAC) is used instead of general anesthesia during minor surgical procedures such as port catheter placement. Nonpharmacological anxiolytics such as aromatherapy have been studied for their effects on preoperative anxiety, but no placebo-controlled study of aromatherapy during surgeries under MAC has yet been performed. Methods: After IRB approval, 70 patients were randomized 1:1 to receive either a lavender/peppermint aromatherapy patch (Elequil Aromatabs®; Beekley Corporation) or a matching placebo patch. The primary outcome, time to readiness for discharge from postoperative acute care units (PACU; min), was assessed every 15 min until a modified postanesthesia recovery score for ambulatory patients (PARSAP) score of 18 or higher was reached. In the preoperative holding area, the assigned patch/placebo was activated and affixed to a folded towel placed aside the subject's head, contralateral to the side of the planned surgery. The towel and patch/placebo were discarded when the subject left the operating room (OR). Results: No difference was found between the treatment and placebo groups on the primary outcome of time to discharge readiness (mean [standard deviation, SD]: 82 [15] vs. 89 [21] min, respectively, p = 0.131). No difference was found between the treatment and placebo groups on the secondary outcomes of intraoperative midazolam dose, intraoperative opioid dose, intraoperative ondansetron dose, or intraoperative promethazine dose. No difference was found between the treatment and placebo groups in the proportion of subjects requiring rescue postoperative nausea and vomiting (PONV) medication in the PACU or the proportion of subjects requiring opioids in the PACU. No difference was found between the treatment and placebo groups in pain intensity in PACU, average PONV score in PACU, or patient satisfaction in PACU. PACU patient satisfaction was high for both the patch and placebo groups (35/35 [100%] vs. 32/34 [94%] "very satisfied," p = 0.239). Conclusions: Aromatherapy treatment is not indicated intraoperatively to reduce anxiety or the use of antiemetics in patients requiring Port catheter placement. Trial registration: Clinicaltrials.gov, identifier: NCT05328973.

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在监测麻醉护理下进行端口导管置入术时使用薰衣草/薄荷组合香薰贴片不会缩短出院准备时间:随机对照试验。
背景:在口腔导管置入等小型外科手术中使用监测麻醉护理(MAC)代替全身麻醉时,术中焦虑是一个常见问题。非药物抗焦虑药(如芳香疗法)对术前焦虑症的影响已被研究过,但尚未对 MAC 下手术期间的芳香疗法进行安慰剂对照研究。研究方法经 IRB 批准后,70 名患者按 1:1 的比例随机接受薰衣草/薄荷芳香疗法贴片(Elequil Aromatabs®; Beekley Corporation)或相应的安慰剂贴片。每隔 15 分钟评估一次主要结果,即从术后急症监护室(PACU;分钟)准备出院的时间,直到非卧床患者麻醉后恢复评分(PARSAP)达到或超过 18 分。在术前留置区,指定的贴片/安慰剂被激活并贴在受试者头部一侧的折叠毛巾上,该毛巾放置在计划手术的对侧。受试者离开手术室时,毛巾和贴片/安慰剂即被丢弃。结果:治疗组和安慰剂组在出院准备时间这一主要结果上没有差异(平均值[标准差,SD]:82 [15] 分钟 vs. 89 [21] 分钟,P = 0.131)。治疗组和安慰剂组在术中咪达唑仑剂量、术中阿片类药物剂量、术中昂丹司琼剂量或术中异丙嗪剂量等次要结果上没有差异。治疗组和安慰剂组在 PACU 中需要术后恶心呕吐 (PONV) 抢救药物的受试者比例或 PACU 中需要阿片类药物的受试者比例上没有差异。治疗组和安慰剂组在 PACU 疼痛强度、PACU 平均 PONV 评分或 PACU 患者满意度方面均无差异。贴片组和安慰剂组的 PACU 患者满意度都很高(35/35 [100%] vs. 32/34 [94%] "非常满意",p = 0.239)。结论:芳香疗法并不适合在术中减轻需要置入导管的患者的焦虑或止吐药的使用。试验注册:试验注册:Clinicaltrials.gov,标识符:NCT05328973:NCT05328973。
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