Department of Anaesthesiology and Pharmacology, Shri Bhausaheb Hire Govt. Medical College, Dhule, Maharashtra, India.
Indian J Pharmacol. 2012 May;44(3):357-61. doi: 10.4103/0253-7613.96321.
The study was planned to assess the comparative efficacy, safety and duration of analgesia produced by low-dose clonidine and midazolam when used as adjuvant for spinal anesthesia.
This is a randomized, participant and observer blind, prospective, parallel group clinical trial. Fifty ASA grade I and II patients posted for lower abdominal surgery were randomly allocated into two groups. BC group received spinal clonidine 30 μg and BM group received preservative-free midazolam 2 mg with 15 mg hyperbaric bupivacaine. Postoperative analgesia, analgesic requirement in 24 hours, onset and duration of block, hemodynamic stability and adverse effects were observed (P<0.05 - considered significant, P<0.01 considered highly significant).
The duration of postoperative analgesia was prolonged in BM group (391.64 ± 132.98 min) than BC group (296.60 ± 52.77 min) (P<0.01). The mean verbal rating pain score was significantly less in BM group than BC group (P<0.01). The number of analgesic doses in 24 hours were significantly less in BM group (P<0.05). Nine patients (36%) in BC group required additional analgesia as against none in BM group (P<0.01). The onset of sensory block and peak sensory level was significantly earlier in BM group as compared to BC group. Duration of sensory block was longer in BM group (P<0.05). Subjects in BC group(36%) had bradycardia as compared to none in BM group (P<0.01). Hypotension was observed in 44% patients in BC group as against 16% in BM group (P<0.05).
Postoperative analgesia with clonidine is short lived with some bradycardia. Intrathecal midazolam provides superior analgesia without clinically relevant adverse effects.
本研究旨在评估小剂量可乐定和咪达唑仑作为椎管内麻醉辅助药物时的镇痛效果、安全性和持续时间。
这是一项随机、参与者和观察者双盲、前瞻性、平行组临床试验。选择 50 例 ASA 分级 I 和 II 级行下腹部手术的患者,随机分为两组。BC 组患者接受脊髓内注射可乐定 30μg,BM 组患者接受不含防腐剂的咪达唑仑 2mg 与 15mg 重比重布比卡因。观察术后镇痛、24 小时内的镇痛需求、阻滞起效时间和持续时间、血流动力学稳定性和不良反应(P<0.05-有统计学意义,P<0.01-有高度统计学意义)。
BM 组的术后镇痛持续时间(391.64±132.98min)长于 BC 组(296.60±52.77min)(P<0.01)。BM 组的平均疼痛评分显著低于 BC 组(P<0.01)。24 小时内的镇痛剂量数 BM 组明显少于 BC 组(P<0.05)。BC 组有 9 例(36%)患者需要额外镇痛,而 BM 组没有(P<0.01)。与 BC 组相比,BM 组的感觉阻滞起效时间和最高感觉平面更早。BM 组的感觉阻滞持续时间更长(P<0.05)。BC 组(36%)的患者出现心动过缓,而 BM 组没有(P<0.01)。BC 组有 44%的患者发生低血压,而 BM 组有 16%(P<0.05)。
可乐定的术后镇痛时间短,且伴有心动过缓。鞘内注射咪达唑仑可提供更好的镇痛效果,且无明显不良反应。