Hari Keerthy P, Balakrishna Ramdas, Srungeri Krishna Mohan, Singhvi Nikhil, John Joseph, Islam Mueedul
Department of Oral and Maxillofacial Surgery, The Oxford Dental College Hospital, Bomannahalli, Begur Road, Bangalore, India.
Department of Oral and Maxillofacial Surgery, Navodaya Dental College Hospital, Raichur, 584101 Karnataka India ; #12-10-97/40, Indralok, Paras Garden, Raichur, 584101 Karnataka India.
J Maxillofac Oral Surg. 2015 Sep;14(3):773-83. doi: 10.1007/s12663-014-0676-y. Epub 2014 Sep 2.
The objective of the study was to assess the efficacy of propofol and midazolam as an intravenous sedative agent in minor oral surgical procedures in terms of: (a) the onset of action, (b) heart rate, (c) oxygen saturation, (d) systolic and diastolic blood pressure, (e) respiratory rate, (f) pain during the injection of sedative agent, (g) recovery period, (h) side effects, (i) patient's cooperation during the surgery.
This was a double blind randomized study in which one group of 20 patients received propofol with the induction dose of 0.5 mg/kg and 50 μg/kg/min which was administered by syringe infusion pump as a maintenance dose and the other group received midazolam in a single dose of 75 μg/kg and no maintenance dose was given, instead 5 % dextrose was administered by syringe infusion pump at the rate of 50 μg/kg/min. Since propofol was milky white in colour, a green cloth was covered over the infusion pump in all cases. The surgeon, assistants and observers were blind about the medications which would be given to the patient for sedation. After the administration of the sedative, local anesthesia was achieved with 2 % lignocaine hydrochloride.
The onset of action in propofol group was significant as onset of action was faster. The maximum increase in heart rate in propofol group was at 10 min intraoperatively (Mean ± 80.40 ± 12.73) and that in midazolam group was at 15 min intraoperatively (Mean 79.25 ± 13.44). Post operatively the heart rate decreased near to the baseline value in both the groups. The average oxygen saturation before induction in propofol group was 99.7 ± 0.73 % and that of midazolam group was 99.15 ± 01.31 P = 0.314. None of the patients in this study developed apnea. The systolic blood pressure (Mean ± SD) before induction in both the groups decreased from the baseline value after the administration of sedatives. The diastolic blood pressure (Mean ± SD) before induction in both the groups decreased from the baseline value after the administration of sedatives and the decreased diastolic blood pressure was maintained throughout the procedure. The respiratory rate (Mean ± SD) before induction in both the groups decreased from the baseline value after the administration of sedatives. The decreased respiratory rate remained throughout the surgical procedure. Pain during the injection of the sedatives was reported by nine patients (45 %) in the propofol group whereas none of the patients in midazolam group complained of pain during the injection. This is statistically significant (P = 0.001). The recovery time (Mean ± SD) in propofol group was 22.50 ± 3.04 (range 15-25 min) and that in midazolam group was 33.75 ± 3.93 (range 30-40 min), which was statistically significant (P < 0.001). Patients in the propofol group were significantly less co-operative than midazolam group at both 10 and 25 min intra operatively.
The design of the present study permitted qualitative assessment of propofol and midazolam as sedative agents in minor oral surgical procedures. The ideal anesthetic agent should provide rapid onset of action, profound intra operative amnesia while ensuring rapid recovery without much complications. There were no significant differences in either patient demographics or surgical characteristics between the two groups. The propofol group was less co-operative than midazolam group. Pain during the injection of sedative was a significant adverse effect in the propofol group. Cardiovascular parameters remained stable throughout the procedure in both study groups and no intervention was required. However recovery and onset of action was faster in the propofol group as compared with the midazolam group.
本研究的目的是评估丙泊酚和咪达唑仑作为静脉镇静剂在小型口腔外科手术中的疗效,评估内容包括:(a)起效时间,(b)心率,(c)血氧饱和度,(d)收缩压和舒张压,(e)呼吸频率,(f)注射镇静剂时的疼痛,(g)恢复期,(h)副作用,(i)手术过程中患者的配合度。
这是一项双盲随机研究,一组20名患者接受丙泊酚,诱导剂量为0.5mg/kg,维持剂量通过注射器输液泵以50μg/kg/min的速度给药;另一组接受咪达唑仑,单次剂量为75μg/kg,不给予维持剂量,而是通过注射器输液泵以50μg/kg/min的速度给予5%葡萄糖。由于丙泊酚呈乳白色,所有情况下输液泵上均覆盖一块绿色布。外科医生、助手和观察者对给予患者用于镇静的药物不知情。给予镇静剂后,用2%盐酸利多卡因进行局部麻醉。
丙泊酚组起效迅速。丙泊酚组术中心率最大增幅出现在10分钟时(平均值±80.40±12.73),咪达唑仑组出现在术中15分钟时(平均值79.25±13.44)。术后两组心率均降至接近基线值。丙泊酚组诱导前平均血氧饱和度为99.7±0.73%,咪达唑仑组为99.15±01.31,P=0.314。本研究中没有患者出现呼吸暂停。两组诱导前收缩压(平均值±标准差)在给予镇静剂后均从基线值下降。两组诱导前舒张压(平均值±标准差)在给予镇静剂后均从基线值下降,且整个手术过程中舒张压持续下降。两组诱导前呼吸频率(平均值±标准差)在给予镇静剂后均从基线值下降。呼吸频率下降在整个手术过程中持续存在。丙泊酚组有9名患者(45%)报告注射镇静剂时疼痛,而咪达唑仑组没有患者抱怨注射时疼痛。这具有统计学意义(P=0.001)。丙泊酚组恢复时间(平均值±标准差)为22.50±3.04(范围15 - 25分钟),咪达唑仑组为33.75±3.93(范围30 - 40分钟),具有统计学意义(P<0.001)。术中10分钟和25分钟时,丙泊酚组患者的配合度明显低于咪达唑仑组。
本研究的设计允许对丙泊酚和咪达唑仑作为小型口腔外科手术镇静剂进行定性评估。理想的麻醉剂应起效迅速,术中产生深度遗忘,同时确保快速恢复且并发症少。两组患者的人口统计学特征或手术特点均无显著差异。丙泊酚组的配合度低于咪达唑仑组。注射镇静剂时的疼痛是丙泊酚组的一个显著不良反应。两个研究组在整个手术过程中心血管参数均保持稳定,无需干预。然而,与咪达唑仑组相比,丙泊酚组的恢复和起效更快。