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咪达唑仑减轻手术应激:一项随机临床试验。

Midazolam in the reduction of surgical stress: a randomized clinical trial.

作者信息

Jerjes Waseem, Jerjes Walid K, Swinson Brian, Kumar Samintharaj, Leeson Rachel, Wood Peter J, Kattan Meir, Hopper Colin

机构信息

Department of Oral and Maxillofacial Surgery, Eastman Dental Institute for Oral Healthcare Sciences, London, UK.

出版信息

Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Nov;100(5):564-70. doi: 10.1016/j.tripleo.2005.02.087.

Abstract

OBJECTIVE

The objective of this study was to assess the role of midazolam in reducing surgical stress as measured using subjective and objective variables.

STUDY DESIGN

The study was a double-blind randomized controlled trial. Thirty-eight male patients undergoing surgical removal of third molars under general anesthesia were recruited for this study, each patient was given premedication (midazolam or placebo) and subjective variables (HAD scale) were obtained and objective variables (salivary cortisol samples and vital signs) were collected pre-, peri-, and postoperatively. The salivary samples were analyzed by direct immunofluorimetric assay using the "DELFIA" system.

RESULTS

There were no significant differences in anxiety between the treatment group and the control group before the administration of the premedication. Following the administration of premedication, the majority of the control group showed high cortisol levels on the day of surgery, compared with relatively low cortisol levels in the majority of the treatment group. A few patients in the control group gave a placebo effect (sedative effect) and a number of the treatment group were unresponsive to the drug. There was a slight drop in the blood pressure and respiration rate with a slight increase in the heart rate in the treatment group; however these results were not statistically significant. The HAD scores were not statistically different between the 2 groups.

CONCLUSION

Midazolam has proved to be very successful in reducing anxiety and stress pre-, peri-, and postoperatively with no significant effect on the vital signs of a healthy patient. Salivary cortisol technique is an easy, noninvasive method to assess anxiety and stress level in patients undergoing surgery.

摘要

目的

本研究的目的是评估咪达唑仑在减轻手术应激方面的作用,通过主观和客观变量进行测量。

研究设计

本研究为双盲随机对照试验。招募了38名接受全身麻醉下第三磨牙手术切除的男性患者,每位患者接受术前用药(咪达唑仑或安慰剂),并在术前、术中及术后获取主观变量(HAD量表)并收集客观变量(唾液皮质醇样本和生命体征)。唾液样本采用“DELFIA”系统通过直接免疫荧光分析法进行分析。

结果

在给予术前用药前,治疗组和对照组在焦虑方面无显著差异。给予术前用药后,与治疗组大多数患者相对较低的皮质醇水平相比,对照组大多数患者在手术当天皮质醇水平较高。对照组中有少数患者出现安慰剂效应(镇静作用),而治疗组中有一些患者对药物无反应。治疗组血压和呼吸频率略有下降,心率略有上升;然而,这些结果无统计学意义。两组的HAD评分无统计学差异。

结论

已证明咪达唑仑在术前、术中和术后减轻焦虑和应激方面非常成功,对健康患者的生命体征无显著影响。唾液皮质醇技术是一种评估手术患者焦虑和应激水平的简便、无创方法。

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