Department of Anesthesiology, Shenzhen University General Hospital, Shenzhen University, Xueyuan AVE 1098, Nanshan District, Shenzhen, Guangdong, 518055, China.
Department of Anesthesiology, First Affiliated Hospital of Kunming Medical University, No. 295 Xichang Road, Kunming, Yunnan, 650032, China.
BMC Anesthesiol. 2022 Dec 21;22(1):398. doi: 10.1186/s12871-022-01930-z.
The aim of this prospective randomized double-blind study is to evaluate whether oral dexmedetomidine (DEX) premedication could increase sedation in order to reduce preoperative anxiety and inhibit stress response during general anesthesia tracheal intubation.
A total of 100 ASA I and II adult patients undergoing elective neurosurgery were randomly divided into the control group (C group, n = 50) and the oral DEX premedication (DEX group, n = 50). Patients were administrated 4 μg/kg dexmedetomidine orally pre-anesthesia 120 min. Hemodynamic variables were monitored and recorded from premedication to 10 min after tracheal intubation. The primary outcome, the sedation level of all participants, was evaluated by Richmond Agitation Sedation Scale (RASS), and Numerical Rating Scale was to measure their intensity of thirst and satisfaction of patients' family members. During general anesthesia induction, the total dosage of induction anesthetics and complications relative to anesthesia induction were recorded. After tracheal intubation, blood sample was drain from radial atrial line to measure levels of adrenocorticotropic hormone (ACTH) and cortisol.
RASS scores at 60 min after premedication and on arrival in the operating room were significantly reduced in the DEX group (P < 0.001). Oral DEX premedication not only increased the intensity of thirst but also the satisfaction of their family members (P < 0.001). The cortisol level after tracheal intubation was deduced by oral DEX premedication (P < 0.05). Oral DEX premedication reduced heart rate (HR) and mean arterial pressure (MAP) on arrival in the operating room, and HR when tracheal intubation (P < 0.05). During the whole process of anesthesia induction, although the lowest MAP in two groups were not significantly different, the lowest HR was significantly lower in the DEX group (P < 0.05). Oral DEX premedication might reduce HR from premedication to 10 min after tracheal intubation. However MAP was reduced just from premedication to on arrival in the operating room. Total induction dosages of propofol, midazolam, sulfentanil and rocuronium were similar in two groups (P > 0.05), as well as the complications relative to anesthesia induction and cases of rescue dopamine therapy were similar (P > 0.05).
Oral DEX 4 μg/kg premedication was an efficient intervention to increase preoperative sedation and reduce stress reaction induced by general anesthesia tracheal intubation, but also it was with the stable hemodynamic during the process of general anesthesia tracheal intubation, and improved the satisfaction of patients' family members. In this study, the sparing-anesthetic effect of 4 μg/kg DEX oral premedication was not significant, and this would be needed to study in future.
This trail was registered at Chinese Clinical Trial Registry ( https://www.chictr.org.cn , Jie Gao) on 15/04/2021, registration number was ChiCTR2100045458.
本前瞻性随机双盲研究旨在评估口服右美托咪定（DEX）预给药是否可以增加镇静作用，以减轻全身麻醉气管插管期间的术前焦虑并抑制应激反应。
100 例择期行神经外科手术的 ASA I 和 II 级成年患者被随机分为对照组（C 组，n = 50）和口服 DEX 预给药组（DEX 组，n = 50）。患者在麻醉前 120 分钟口服 4μg/kg 右美托咪定。监测并记录从预给药到气管插管后 10 分钟的血流动力学变量。主要结局是所有参与者的镇静水平，由 Richmond 躁动镇静量表（RASS）评估，以及通过数字评分量表测量患者口渴和家属满意度的强度。在全身麻醉诱导期间，记录诱导麻醉的总剂量和与麻醉诱导相关的并发症。气管插管后，从桡动脉线抽取血样以测量促肾上腺皮质激素（ACTH）和皮质醇水平。
预给药后 60 分钟和到达手术室时，DEX 组的 RASS 评分显著降低（P < 0.001）。口服 DEX 预给药不仅增加了口渴的强度，还增加了家属的满意度（P < 0.001）。口服 DEX 预给药降低了气管插管后的皮质醇水平（P < 0.05）。口服 DEX 预给药降低了到达手术室时的心率（HR）和平均动脉压（MAP），以及气管插管时的 HR（P < 0.05）。在整个麻醉诱导过程中，虽然两组的最低 MAP 没有显著差异，但 DEX 组的最低 HR 明显更低（P < 0.05）。口服 DEX 预给药可能会降低从预给药到气管插管后 10 分钟的 HR。然而，MAP 仅从预给药降低到到达手术室时。两组丙泊酚、咪达唑仑、舒芬太尼和罗库溴铵的诱导总剂量相似（P > 0.05），与麻醉诱导相关的并发症和多巴胺抢救治疗的病例也相似（P > 0.05）。
口服 4μg/kg DEX 预给药是一种有效的干预措施，可增加术前镇静并减轻全身麻醉气管插管引起的应激反应，但在全身麻醉气管插管过程中也具有稳定的血流动力学，并提高了患者家属的满意度。在本研究中，4μg/kg DEX 口服预给药的节省麻醉效果并不显著，这需要在未来的研究中进一步探讨。
本试验于 2021 年 4 月 15 日在中国临床试验注册中心（www.chictr.org.cn，高杰）注册，注册号为 ChiCTR2100045458。
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