Department of Anesthesiology, Innlandet Hospital Trust, Sykehuset Lillehammer, Anders Sandvigs gate 17, 2609, Lillehammer, Norway.
Department of Anesthesiology, Østfold Hospital Trust, Sykehuset Østfold Kalnes, Kalnesveien 300, 1714, Grålum, Norway.
BMC Anesthesiol. 2022 Feb 28;22(1):57. doi: 10.1186/s12871-022-01593-w.
Assessment of appropriate anesthetic depth is crucial to prevent harm to patients. Unnecessary deep anesthesia can be harmful, potentially causing acute renal failure, myocardial injury, delirium, and an increased mortality rate. Conversely, too light anesthesia combined with muscle relaxants can result in intraoperative patient awareness and lead to serious psychological trauma. This trial aimed to ascertain the effectiveness of the advisory display SmartPilot® View (SPV), as a supplemental measure in the assessment of anesthetic depth in low risk gynecological surgery patients. The hypothesis was that the use of the SPV would increase the precision of assessment, and result in a higher mean arterial pressure.
This trial used a randomized, controlled, single-blind design with a homogeneous sample. Patients undergoing minor, low risk gynecological surgery were randomly assigned to two groups: a test group wherein current standards were supplemented with the advisory display SPV and a control group assessed using only the current standards. Female patients aged between 18 and 75 years with American Society of Anesthesiologists Physical Status Classification System scores of 1-3 undergoing planned general anesthesia using the total intravenous anesthetic method, combining propofol and remifentanil, were included. The exclusion criteria included a body mass index ≥ 35 kg/m, a history of alcoholism, drug intake affecting propofol and remifentanil dynamics, and inability to consent. The independent sample t-test and chi-square test or Fisher's exact test were used to assess the statistical significance of differences between the two groups.
A total of 114 patients were included in the analysis (test group n = 58, control group n = 56). No significant differences in the mean arterial pressure, heart rate, bispectral index, extubation delay, or post-anesthesia care unit stay were found between groups.
The addition of the advisory display SmartPilot® View to current standards in the evaluation of anesthetic depth had no significant effect on the outcome.
The trial was registered on January 16th 2019 with ClinicalTrials.gov (ref: NCT03807271 ).
评估适当的麻醉深度对于防止患者受到伤害至关重要。不必要的深度麻醉可能有害，可能导致急性肾衰竭、心肌损伤、谵妄和死亡率增加。相反，过浅的麻醉加上肌肉松弛剂可能导致术中患者意识，并导致严重的心理创伤。本试验旨在确定顾问式显示 SmartPilot® View（SPV）作为评估低危妇科手术患者麻醉深度的辅助措施的有效性。假设是使用 SPV 将提高评估的准确性，并导致更高的平均动脉压。
本试验采用随机、对照、单盲设计，样本同质。接受小、低危妇科手术的患者被随机分配到两组：一组在当前标准的基础上补充顾问式显示 SPV，另一组仅使用当前标准进行评估。纳入标准为：年龄 18-75 岁、美国麻醉医师协会身体状况分级系统评分 1-3 分、计划全身麻醉、采用全静脉麻醉方法、联合使用丙泊酚和瑞芬太尼的女性患者。排除标准包括体重指数≥35 kg/m、酗酒史、药物摄入影响丙泊酚和瑞芬太尼动力学、无法同意。采用独立样本 t 检验和卡方检验或 Fisher 确切检验评估两组间差异的统计学意义。
共纳入 114 例患者进行分析（试验组 n=58，对照组 n=56）。两组间平均动脉压、心率、双谱指数、拔管延迟或麻醉后恢复室停留时间无显著差异。
在评估麻醉深度时，在当前标准的基础上增加顾问式显示 SmartPilot® View 对结果没有显著影响。
该试验于 2019 年 1 月 16 日在 ClinicalTrials.gov 注册（注册号：NCT03807271）。
