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依托咪酯靶控输注复合氯胺酮与依托咪酯靶控输注用于支气管超声引导经支气管针吸活检术患者深度镇静:一项前瞻性、随机、对照临床试验。

Esketamine Combined with Propofol TCI versus Propofol TCI for Deep Sedation during Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration: A Prospective, Randomized, and Controlled Trial.

机构信息

Department of Anesthesiology, The Second Hospital of Hebei Medical University, Shijiazhuang 050000, China.

Department of Pneumology, The Second Hospital of Hebei Medical University, Shijiazhuang 050000, China.

出版信息

Int J Clin Pract. 2023 Dec 11;2023:1155126. doi: 10.1155/2023/1155126. eCollection 2023.

Abstract

BACKGROUND

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is an invasive procedure that required deep sedation to suppress coughing and body movements. Deep sedation, on the other hand, has been shown to cause respiratory and circulatory depression, especially when the airway is shared with the endoscopist. Esketamine is a novel sedative and analgesic with little respiratory inhibition that appears to be an appropriate adjuvant in propofol sedation for EBUS-TBNA. We compared the efficacy and safety of esketamine combined with propofol target-controlled infusion (TCI) and propofol TCI for deep sedation in EBUS-TBNA.

METHODS

The study included 135 patients with ASA II-III undergoing EBUS-TBNA. They were randomly divided into two groups (group E and group P). Both groups received midazolam (0.01-0.03 mg/kg) and oxycodone (0.07-0.08 mg/kg). Then, patients in group E received 0.3 mg/kg esketamine, propofol TCI, and 0.2 mg·kg·h esketamine for sedative maintenance. Patients in group P received only propofol TCI. The primary outcome was the dose of 1% lidocaine administrated by the endoscopist and the times of lidocaine sprays. Secondary outcome indicators were cough score, propofol dosage, patient satisfaction, endoscopist satisfaction, the incidence of sedation-related adverse effects and side effects, and recovery time.

RESULTS

Patients in group E were given significantly less lidocaine (4.36 ml/h (2.67-6.00) vs 6.00 ml/h (4.36-7.20), < 0.001) and less spraying frequency (2.18 times/h (1.33-3.00) vs 3.00 times/h (2.18-3.60), < 0.001) than group P. There was a statistically significant difference in cough score between the two groups (group E 2 (0-4) vs group P 3 (2-4), =0.03). Also, mean arterial pressure (MAP) was higher in group E in the 30 min (T5, 84.10 ± 12.91 mmHg versus 79.04 ± 10.01 mmHg, =0.012) and 40 min (T6, 87.72 ± 15.55 mmHg versus 82.14 ± 10.51 mmHg, =0.026). There were no significant differences between the two groups in terms of sedation-related adverse events and side effects, recovery time, endoscopist satisfaction, and patient satisfaction.

CONCLUSIONS

In patients with ASA II-III, esketamine as an adjuvant in combination with propofol TCI deep sedation for EBUS-TBNA can improve the sedation effect, reduce coughing reaction during the procedure, and obtain more stable blood pressure. No reduction in the occurrence of sedation-related side effects was observed. This trial is registered with ChiCTR2200061124.

摘要

背景

经支气管超声引导针吸活检术(EBUS-TBNA)是一种有创性操作,需要深度镇静以抑制咳嗽和身体运动。另一方面,深度镇静已被证明会导致呼吸和循环抑制,特别是当气道与内镜医生共享时。依托咪酯是一种新型镇静和镇痛药物,呼吸抑制作用小,似乎是在依托咪酯镇静下进行 EBUS-TBNA 的合适辅助药物。我们比较了依托咪酯联合依托咪酯靶控输注(TCI)和依托咪酯 TCI 在 EBUS-TBNA 中进行深度镇静的疗效和安全性。

方法

该研究纳入了 135 名 ASA II-III 级接受 EBUS-TBNA 的患者。他们被随机分为两组(E 组和 P 组)。两组均给予咪达唑仑(0.01-0.03mg/kg)和羟考酮(0.07-0.08mg/kg)。然后,E 组患者给予 0.3mg/kg 依托咪酯、依托咪酯 TCI 和 0.2mg·kg·h 依托咪酯维持镇静。P 组患者仅给予依托咪酯 TCI。主要结局指标是内镜医生给予的 1%利多卡因剂量和利多卡因喷雾次数。次要结局指标为咳嗽评分、依托咪酯剂量、患者满意度、内镜医生满意度、镇静相关不良反应和副作用的发生率以及恢复时间。

结果

E 组患者给予的利多卡因明显较少(4.36ml/h(2.67-6.00)比 6.00ml/h(4.36-7.20),<0.001),喷雾频率也较低(2.18 次/h(1.33-3.00)比 3.00 次/h(2.18-3.60),<0.001)。两组咳嗽评分有统计学差异(E 组 2(0-4)比 P 组 3(2-4),=0.03)。此外,E 组在 30 分钟(T5,84.10±12.91mmHg 比 79.04±10.01mmHg,=0.012)和 40 分钟(T6,87.72±15.55mmHg 比 82.14±10.51mmHg,=0.026)时的平均动脉压(MAP)更高。两组在镇静相关不良反应和副作用、恢复时间、内镜医生满意度和患者满意度方面无显著差异。

结论

在 ASA II-III 级患者中,依托咪酯作为辅助药物联合依托咪酯 TCI 深度镇静用于 EBUS-TBNA 可改善镇静效果,减少操作过程中的咳嗽反应,并获得更稳定的血压。未观察到镇静相关副作用发生率降低。本试验在中国临床试验注册中心注册,注册号为 ChiCTR2200061124。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f6ba/10728353/1aa01aa2f4e1/IJCLP2023-1155126.001.jpg

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