Gold M I, Watkins W D, Sung Y F, Yarmush J, Chung F, Uy N T, Maurer W, Clarke M Y, Jamerson B D
University of Miami, Anesthesia Service, Veterans Administration Medical Center, Florida 33125, USA.
Anesthesiology. 1997 Jul;87(1):51-7. doi: 10.1097/00000542-199707000-00007.
This study was designed to define the appropriate dose of remifentanil hydrochloride alone or combined with midazolam to provide satisfactory comfort and maintain adequate respiration for a monitored anesthesia care setting.
One hundred fifty-nine patients scheduled for outpatient surgery participated in this multicenter, double-blind study. Patients were randomly assigned to one of two groups: remifentanil, 1 microgram/kg, given over 30 s followed by a continuous infusion of 0.1 microgram.kg-1.min-1 (remifentanil), remifentanil, 0.5 microgram/kg, given over 30 s followed by a continuous infusion of 0.05 microgram.kg-1.min-1 (remifentanil+midazolam). Five minutes after the start of the infusion, patients received a loading dose of saline placebo (remifentanil) or midazolam, 1 mg, (remifentanil+midazolam). If patients were not oversedated, a second dose of placebo or midazolam, 1 mg, was given. Remifentanil was titrated (in increments of 50% from the initial rate) to limit patient discomfort or pain intraoperatively, and the infusion was terminated at the completion of skin closure.
At the time of the local anesthetic, most patients in the remifentanil and remifentanil+midazolam groups experienced no pain (66% and 60%, respectively) and no discomfort (66% and 65%, respectively). The final mean (+/-SD) remifentanil infusion rates were 0.12 +/- 0.05 microgram.kg-1.min-1 (remifentanil) and 0.07 +/- 0.03 microgram.kg-1.min-1 (remifentanil+midazolam). Fewer patients in the remifentanil+midazolam group experienced nauses compared with the remifentanil group (16% vs. 36%, respectively; P < 0.05). Four patients (5%) in the remifentanil group and two patients (2%) in the remifentanil+midazolam group experienced brief periods of oxygen desaturation (SpO2 < 90%) and hypoventilation (< 8 breaths/ min).
Remifentanil alone or combined with midazolam provided adequate analgesia and maintained adequate respiration at the doses reported. The low dose of remifentanil combined with 2 mg midazolam, compared with remifentanil alone, resulted in fewer side effects, slightly greater sedation, and less anxiety.
本研究旨在确定单独使用盐酸瑞芬太尼或联合咪达唑仑的合适剂量，以便在麻醉监测护理中提供满意的舒适度并维持充分的呼吸。
159例计划接受门诊手术的患者参与了这项多中心、双盲研究。患者被随机分为两组：瑞芬太尼组，1μg/kg，在30秒内给予，随后以0.1μg·kg⁻¹·min⁻¹持续输注（瑞芬太尼组）；瑞芬太尼+咪达唑仑组，0.5μg/kg，在30秒内给予，随后以0.05μg·kg⁻¹·min⁻¹持续输注（瑞芬太尼+咪达唑仑组）。输注开始5分钟后，患者接受生理盐水安慰剂（瑞芬太尼组）或咪达唑仑1mg（瑞芬太尼+咪达唑仑组）的负荷剂量。如果患者未出现过度镇静，则给予第二剂安慰剂或咪达唑仑1mg。瑞芬太尼进行滴定（从初始速率开始以50%的增量增加）以限制术中患者的不适或疼痛，皮肤缝合完成后停止输注。
在局部麻醉时，瑞芬太尼组和瑞芬太尼+咪达唑仑组的大多数患者无疼痛（分别为66%和60%）且无不适（分别为66%和百分之65%）。最终瑞芬太尼的平均（±标准差）输注速率在瑞芬太尼组为0.12±0.05μg·kg⁻¹·min⁻¹，在瑞芬太尼+咪达唑仑组为0.07±0.03μg·kg⁻¹·min⁻¹。与瑞芬太尼组相比，瑞芬太尼+咪达唑仑组恶心的患者较少（分别为16%和36%；P<0.05）。瑞芬太尼组有4例患者（5%）和瑞芬太尼+咪达唑仑组有2例患者（2%）经历了短暂的氧饱和度降低（SpO₂<90%）和通气不足（<8次/分钟）。
单独使用瑞芬太尼或联合咪达唑仑在报告的剂量下提供了充分的镇痛并维持了充分的呼吸。与单独使用瑞芬太尼相比，低剂量瑞芬太尼联合2mg咪达唑仑导致的副作用更少、镇静作用稍强且焦虑感更低。
