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用于除皱整形术的双谱指数监测静脉麻醉与吸入麻醉对比:一项随机临床试验

Intravenous Anesthesia With Bispectral Index Monitoring vs Inhalational Anesthesia for Rhytidoplasty: A Randomized Clinical Trial.

作者信息

Jones Kristin A, LaFerriere Keith A

机构信息

Lexington Facial Plastic Surgery, Lexington, Kentucky.

Mercy Facial Plastic Surgery Center, Springfield, Missouri.

出版信息

JAMA Facial Plast Surg. 2015 Jul-Aug;17(4):239-44. doi: 10.1001/jamafacial.2015.0222.

Abstract

IMPORTANCE

Minor adverse effects related to anesthesia are common and worrisome to patients, including perioperative vomiting, gagging on the endotracheal tube, incisional pain, and nausea. A previously published intravenous anesthesia protocol reports extremely low rates of postoperative nausea and vomiting (<1%) and decreases in postoperative pain perception compared with rates reported following administration of inhalational anesthetics.

OBJECTIVE

To evaluate and compare postoperative outcomes in patients after administration of combined propofol and ketamine hydrochloride anesthesia with bispectral index monitoring (PKA-BIS protocol) vs inhalational anesthesia (IA) during lower rhytidoplasty.

DESIGN, SETTING, AND PARTICIPANTS: We performed a prospective, double-blind, randomized comparison trial of the PKA-BIS protocol and IA in 30 consecutive female patients undergoing rhytidoplasty by a single surgeon at a single outpatient surgery center from October 2013 to June 2014.

MAIN OUTCOMES AND MEASURES

Outcome measures included nausea, vomiting, pain, overall feeling of well-being, time to awaken, time to discharge, and cost. Patient measures were recorded using a combination of a 40-item validated postoperative quality of recovery questionnaire (QOR-40) and visual analog scales (VASs). Results were recorded immediately after surgery and on postoperative days 1 and 7.

RESULTS

A statistically significant reduction in emergence time (mean [SD], 29.8 [10.6] vs 46.0 [10.2] minutes; P < .001) and time to meet discharge criteria (51.4 [19.3] vs 66.1 [12.9] minutes; P = .02) was seen in patients in the PKA-BIS group. Patient-reported (subjective) postoperative nausea (3 of 15 [20%] vs 7 of 15 patients [47%]; P = .12; χ2 = 2.40), vomiting (0 vs 2 of 15 patients [13%]; P = .14; χ2 = 2.14), and confusion on the day of surgery (3 of 15 [20%] vs 6 of 14 patients [43%]; P = .18; χ2 = 1.77) were also decreased in the PKA-BIS group, but these differences did not reach significance. Differences in global recovery scores (QOR-40 scores in the postanesthesia care unit, 158.13 [22.68] vs 155.33 [18.09]; P = .71; at day 1, 166.47 [26.39] vs 166.00 [16.00]; P = .96), postoperative overall feeling of well-being (VAS scores at day 1, 6.10 vs 6.26; at day 7, 7.49 vs 8.00), and postoperative pain perception (VAS scores at day 1, 3.40 vs 3.65; at day 7, 2.26 vs 1.81) between the PKA-BIS and IA groups, respectively, did not reach significance. The costs of anesthesia administration were similar between the PKA-BIS ($10.37/h) and IA ($8.47/h to $9.87/h) groups.

CONCLUSIONS AND RELEVANCE

The PKA-BIS protocol for anesthesia appears to be a comparable alternative to traditional IA in patients undergoing elective rhytidoplasty. A larger patient sample size is needed to determine whether trends toward decreased nausea, vomiting, and postoperative confusion and differences in postoperative pain perception are significant.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT02410460.

LEVEL OF EVIDENCE

摘要

重要性

与麻醉相关的轻微不良反应很常见,且令患者担忧,包括围手术期呕吐、气管插管时呛咳、切口疼痛和恶心。先前发表的一项静脉麻醉方案报告称,与吸入性麻醉剂给药后的发生率相比,术后恶心和呕吐的发生率极低(<1%),且术后疼痛感知有所降低。

目的

评估并比较在低位除皱术中,接受丙泊酚和盐酸氯胺酮联合麻醉并进行脑电双频指数监测(PKA - BIS方案)与吸入性麻醉(IA)的患者的术后结局。

设计、地点和参与者:我们于2013年10月至2014年6月在一个门诊手术中心,对30例连续接受一名外科医生进行除皱术的女性患者进行了PKA - BIS方案与IA的前瞻性、双盲、随机对照试验。

主要结局和指标

结局指标包括恶心、呕吐、疼痛、总体幸福感、苏醒时间、出院时间和费用。使用一份经过验证的40项术后恢复质量问卷(QOR - 40)和视觉模拟量表(VAS)相结合的方式记录患者指标。结果在术后即刻以及术后第1天和第7天进行记录。

结果

PKA - BIS组患者的苏醒时间(平均[标准差],29.8[10.6]分钟对46.0[10.2]分钟;P <.001)和达到出院标准的时间(51.4[19.3]分钟对66.1[12.9]分钟;P =.02)有统计学显著降低。PKA - BIS组患者报告的(主观)术后恶心(15例中的3例[20%]对15例患者中的7例[47%];P =.12;χ2 = 2.40)、呕吐(15例中的0例对15例患者中的2例[13%];P =.14;χ2 = 2.14)以及手术当天的意识模糊(15例中的3例[20%]对14例患者中的6例[43%];P =.18;χ2 = 1.77)也有所减少,但这些差异未达到显著水平。PKA - BIS组与IA组之间的总体恢复评分(麻醉后护理单元的QOR - 40评分,158.13[22.68]对155.33[18.09];P =.71;术后第1天,166.47[26.39]对166.00[16.00];P =.96)、术后总体幸福感(术后第1天的VAS评分,6.10对6.26;术后第7天,7.49对8.00)以及术后疼痛感知(术后第1天的VAS评分,3.40对3.65;术后第7天,2.26对1.81)的差异均未达到显著水平。PKA - BIS组(10.37美元/小时)与IA组(8.47美元/小时至9.87美元/小时)的麻醉给药费用相似。

结论及相关性

对于接受择期除皱术的患者,PKA - BIS麻醉方案似乎是传统IA的一种可比替代方案。需要更大的患者样本量来确定恶心、呕吐和术后意识模糊减少的趋势以及术后疼痛感知差异是否显著。

试验注册

clinicaltrials.gov标识符:NCT02410460。

证据级别

1级。

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