BACKGROUND The effectiveness and side effects of dexmedetomidine (DEX) in combination with midazolam and propofol have not been comparatively studied in a single clinical trial as sedative agents to general anesthesia before. OBJECTIVE The objective of this study is to compare intra and post-operative sedation between DEX-Midazolam and DEX-Propofol in patients who underwent major abdominal surgery on the duration of general anesthesia, hemodynamic and sedation effect. METHOD This prospective, randomized, double-blinded clinical trial included 50 patients who were 20 to 60 years of age and admitted for major abdominal surgery. The patients were randomly assigned by a computer-generated random numbers table to sedation with DEX plus midazolam (DM group) (n=25) or DEX plus propofol (DP group) (n=25). In the DM group, patients received a bolus dose of 0.1 mg/kg of midazolam and immediately initiated the intravenous (i.v.) infusion of DEX 1 μg/kg over a 10 min and 0.5 μg/kg/hr by continuous i.v. infusion within operation period. In the DP group, patients received pre-anesthetic i.v. DEX 1 μg/kg over 15 min before anesthesia induction and 0.2-1 μg/kg/hr by continuous i.v. infusion during the operative period. After preoxygenation for at least 2 min, during the surgery, patients received propofol infusion dose of 250 μg/kg/min for 15 min then a basal infusion dose of 50 μg/kg/min. The bispectral index (BIS) value, as well as mean arterial pressure (MAP), heart rate (HR), respiratory rate (RR), oxygen saturation (SaO2), percutaneous arterial oxygen saturation (SpO2) and end-tidal carbon dioxide tension (ETCO2) were recorded before anesthesia (T0), during anesthesia (at 15-min intervals throughout the surgical procedure), by a blinded observer. Evidence of apnea, hypotension, hypertension and hypoxemia were recorded during surgery. RESULTS The hemodynamic changes, including HR, MAP, BIS, VT, SaO2, and RR had a downward tendency with time, but no significant difference was observed between the groups (P>0.05). However, the two groups showed no significant differences in ETCO2 and SPO2 values in any of the assessed interval (P>0.05). In this study, the two groups showed no significant differences in the incidence of nausea, vomiting, coughing, apnea, hypotension, hypertension, bradycardia and hypoxemia (P>0.05). Respiratory depression and serious adverse events were not reported in either group. Extubation time after surgery was respectively 6.3 ± 1.7 and 5.8 ± 1.4 hr. in the DM and DP groups and the difference was not statistically significant (P= 0.46). CONCLUSION Our study showed no significant differences between the groups in hemodynamic and respiratory changes in each of the time intervals. There were also no significant differences between the two groups in the incidence of complication intra and post-operative. Further investigations are required to specify the optimum doses of using drugs which provide safety in cardiovascular and respiratory system without adverse disturbance during surgery.

中文翻译：

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右美托咪定咪达唑仑和右美托咪定丙泊酚用于腹部大手术的术中和术后镇静效果比较。

背景 右美托咪定（DEX）联合咪达唑仑和丙泊酚作为全身麻醉镇静剂的单一临床试验的有效性和副作用之前尚未进行过比较研究。目的本研究的目的是比较DEX-咪达唑仑和DEX-丙泊酚在腹部大手术患者中对全身麻醉持续时间、血流动力学和镇静效果的影响。方法 这项前瞻性、随机、双盲临床试验包括 50 名年龄在 20 至 60 岁并因腹部大手术入院的患者。通过计算机生成的随机数字表将患者随机分配到使用 DEX 加咪达唑仑（DM 组）（n=25）或 DEX 加丙泊酚（DP 组）（n=25）进行镇静。在DM组中，患者接受了 0.1 mg/kg 咪达唑仑的推注剂量，并立即开始在 10 分钟内静脉 (iv) 输注 DEX 1 μg/kg，并在手术期间通过连续 iv 输注 0.5 μg/kg/hr。DP组患者在麻醉诱导前15分钟内接受麻醉前静脉注射DEX 1 μg/kg，在手术期间连续静脉滴注0.2-1 μg/kg/hr。预氧合至少 2 分钟后，在手术过程中，患者接受 250 μg/kg/min 的异丙酚输注剂量 15 分钟，然后以 50 μg/kg/min 的基础输注剂量。双谱指数 (BIS) 值，以及平均动脉压 (MAP)、心率 (HR)、呼吸频率 (RR)、血氧饱和度 (SaO2)、经皮动脉血氧饱和度 (SpO2) 和呼气末二氧化碳分压（ETCO2）在麻醉前（T0）记录，在麻醉期间（在整个手术过程中每隔 15 分钟），由不知情的观察者进行。在手术过程中记录了呼吸暂停、低血压、高血压和低氧血症的证据。结果HR、MAP、BIS、VT、SaO2、RR等血流动力学变化随时间呈下降趋势，但组间差异无统计学意义（P>0.05）。然而，两组在任何评估区间内的ETCO2和SPO2值均无显着差异（P>0.05）。本次研究中，两组恶心、呕吐、咳嗽、呼吸暂停、低血压、高血压、心动过缓、低氧血症发生率差异无统计学意义（P>0.05）。两组均未报告呼吸抑制和严重不良事件。术后拔管时间分别为 6.3 ± 1.7 和 5.8 ± 1.4 小时。在 DM 和 DP 组中，差异无统计学意义（P = 0.46）。结论 我们的研究表明，各组之间在每个时间间隔内的血流动力学和呼吸变化没有显着差异。两组患者术中术后并发症发生率也无显着差异。需要进一步的研究来确定使用药物的最佳剂量，这些药物可以在手术期间提供心血管和呼吸系统的安全性而不会产生不利的干扰。两组患者术中术后并发症发生率也无显着差异。需要进一步的研究来确定使用药物的最佳剂量，这些药物可以在手术期间提供心血管和呼吸系统的安全性而不会产生不利的干扰。两组患者术中术后并发症发生率也无显着差异。需要进一步的研究来确定使用药物的最佳剂量，这些药物可以在手术期间提供心血管和呼吸系统的安全性而不会产生不利的干扰。