Parworth L P, Frost D E, Zuniga J R, Bennett T
Department of Oral and Maxillofacial Surgery, University of North Carolina, Chapel Hill 27514-7450, USA.
J Oral Maxillofac Surg. 1998 Apr;56(4):447-53; discussion 453-4. doi: 10.1016/s0278-2391(98)90710-8.
The purpose of this study was to measure the safety and efficacy of propofol combined with fentanyl as sedative agents during third molar outpatient surgery.
A double-blind, prospective, randomized clinical trial involving 57 patients undergoing removal of third molars under intravenous sedation between November 1994 and December 1995 was performed. Patients randomly received either propofol and fentanyl (P + F, th = 24) or midazolam and fentanyl (M + F, M = 33). Patient demographics, Corah anxiety scores, and physiologic parameters were determined preoperatively. All medications were titrated to the same clinical end point for sedation. Intraoperative physiologic parameters, cooperation, alertness, and pain scores were assessed. Postoperative recovery and degree of amnesia also were determined.
There were no significant differences in either patient demographics or surgical characteristics between groups. The P + F group was significantly less cooperative than the M + F group. Pain during injection of propofol was a significant adverse side effect. Both groups experienced a small percentage of apneic episodes, but mechanical ventilation was never required. There were no differences in recovery between groups as measured by the Treiger dot test and psychomotor recovery scores. The degree of anterograde amnesia was greater for the M + F group, although the difference was not statistically significant. Sedation was rated good to excellent by the patient, surgeon, and observer, and there were no statistically significant differences between groups.
Propofol appears to be a safe and efficacious drug for use during outpatient oral surgical procedures.
本研究旨在测定丙泊酚联合芬太尼作为镇静剂在第三磨牙门诊手术中的安全性和有效性。
进行了一项双盲、前瞻性、随机临床试验，纳入了1994年11月至1995年12月间57例在静脉镇静下接受第三磨牙拔除术的患者。患者随机接受丙泊酚和芬太尼（P + F组，n = 24）或咪达唑仑和芬太尼（M + F组，n = 33）。术前测定患者人口统计学数据、科拉焦虑评分和生理参数。所有药物均滴定至相同的镇静临床终点。评估术中生理参数、合作程度、清醒程度和疼痛评分。还测定术后恢复情况和遗忘程度。
两组患者的人口统计学数据或手术特征均无显著差异。P + F组的合作程度明显低于M + F组。丙泊酚注射时的疼痛是一种显著的不良副作用。两组均有一小部分出现呼吸暂停发作，但从未需要机械通气。通过特里格点试验和精神运动恢复评分测定，两组之间的恢复情况无差异。M + F组的顺行性遗忘程度更大，尽管差异无统计学意义。患者、外科医生和观察者对镇静的评价为良好至优秀，两组之间无统计学显著差异。
丙泊酚似乎是门诊口腔外科手术中一种安全有效的药物。
