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咪达唑仑,一种新的更强效的苯二氮䓬类药物,与地西泮在脊髓镇痛期间作为镇静剂的比较,一项随机双盲研究。

MIDAZOLAM, A NEW MORE POTENT BENZODIAZEPINE, COMPARED WITH DIAZEPAM AS SEDATIVE DURING SPINAL ANALGESIA, A RANDOMISED DOUBLE BLIND STUDY.

作者信息

Suri Yudhvir, Lamba N S

机构信息

Senior Adviser (Anaesthesiology), Base Hospital, Delhi Cantt, 110 010.

Classified Specialist (Anaesthesiology), 428 Field Ambulance, C/o 56 APO.

出版信息

Med J Armed Forces India. 2000 Jan;56(1):29-32. doi: 10.1016/S0377-1237(17)30086-2. Epub 2017 Jun 8.

Abstract

Midazolam, a new benzodiazepine was compared with diazepam as intraoperative sedative during spinal anaesthesia in a double blind study. Eighty five patients participated in this clinical trial (placebo 25, midazolam 30, diazepam 30). Drug treatment was administered after spinal anaesthesia at 5 min of supine position. Level of spinal anaesthesia in terms of sympathetic blocade was similar in all the patients. Dosage of drug were tailored to the needs of each patient till the end point of undisturbed sleep. Intraoperative sedation based on predetermined criteria, recovery by Trieger's test at 4 hr after the drug administration, antegrade amnesia by memory card and haemodynamics were assessed. Mean doses of 240 μg kg and 500 μg kg of midazolam and diazepam were required to induce sleep which suggest an equivalent dose ratio of midazolam: diazepam as 1: 2.1. Both the drugs produced effective sedation during spinal anaesthesia, 86.6% patient with midazolam and 93.3% patients with diazepam had deep undisturbed sleep. Clinical recovery was fast in midazolam administered patients but did not meet the criteria of early discharge by Trieger's test at 4 hr after the administration of the drug. There were no gross changes in the circulatory effects of the two drugs. Decrease in mean systolic pressure (<10%) and marginal increase in heart rate was seen. The frequency of antegrade amnesia was greater with midazolam. Global assessment as judged by anaesthesiologist and patients satisfaction for anaesthesia and recovery was higher (93.3%) with midazolam as compared to (79.9%) diazepam.

摘要

在一项双盲研究中,将新型苯二氮䓬类药物咪达唑仑与地西泮作为脊髓麻醉期间的术中镇静剂进行了比较。85名患者参与了该临床试验(安慰剂组25例,咪达唑仑组30例,地西泮组30例)。在脊髓麻醉后仰卧位5分钟给予药物治疗。所有患者的交感神经阻滞水平的脊髓麻醉平面相似。根据每位患者的需求调整药物剂量,直至达到安静睡眠的终点。根据预定标准评估术中镇静情况、给药后4小时通过Trieger试验评估恢复情况、通过记忆卡评估顺行性遗忘以及血流动力学情况。诱导睡眠所需的咪达唑仑和地西泮的平均剂量分别为240μg/kg和500μg/kg,这表明咪达唑仑与地西泮的等效剂量比为1:2.1。两种药物在脊髓麻醉期间均产生了有效的镇静作用,86.6%接受咪达唑仑治疗的患者和93.3%接受地西泮治疗的患者获得了深度安静睡眠。接受咪达唑仑治疗的患者临床恢复较快,但在给药后4小时通过Trieger试验未达到早期出院标准。两种药物的循环效应均无明显变化。平均收缩压下降(<10%),心率略有增加。咪达唑仑导致顺行性遗忘的发生率更高。与地西泮(79.9%)相比,麻醉医生判断的总体评估以及患者对麻醉和恢复的满意度,咪达唑仑更高(93.3%)。

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