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临床试验/NCT03791424
NCT03791424已完成4 期

Changes of Skin Resistance After Midazolam and After the End of Anaesthesia

Charles University, Czech Republic1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2014年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
28
试验地点
1
主要终点
Changes of skin resistence (percent from base-line values measured in ohms) during sedation

研究概览

简要总结

It has been described that sympathetic activity, measured as changes in electrical skin resistance (SR), may be used to assess the adequacy of general anaesthesia. Our prospective study investigated how far measurements of skin resistance can help determine level of sedation. The secondary aim was to investigate if changes in skin resistance can be used for assessing recovery from anaesthesia.

详细描述

Introduction Before anaesthesia, benzodiazepines are routinely used to reduce anxiety before anaesthesia and surgery. Usually anxiolysis is preferable to sedation, which may interfere with recovery after short procedures. Unfortunately, although anxiolytic sedatives are widely used in clinical practice, the methodology for assessing treatment effect of these compounds has not been well developed. Psychologic tests like the Hamilton Anxiety Rating Scale (HARS), the Wang Anxiety Rating Scale (WARS), or Zung Self-Rating Anxiety Scale (SAS) were used to assess changes in anxiety were developed for measuring effect of long-term therapy and are rather cumbersome and difficult to use in routine anaesthetic praxis.

More commonly used test in clinical perioperative use are the Ramsay sedation scale (RSS), the Richmond Agitation-Sedation Scale (RASS) and the Observer's Assessment of Alertness and Sedation scale (OAASS), but they focus mainly on level of sedation and not the level of anxiolysis. There are several reports demonstrating that there is a correlation between level of anxiety and changes in skin resistance.

Changes of skin resistance (SI) were first used in criminology in 1897 and in 1921 the method was used in criminology by August Larson together with changes of heart rate, respiratory rate and blood pressure for construction of polygraph. This method was many times validated and polygraph is still used as a "lie detector". More recently sever studies appeared demonstrating correlation between changes of skin resistance and sedation grade, bispectral index, reaction to stimulation, pain and motor activity.

The present double-blinded study was designed to refine methodology for objective evaluating effect of sedative and anxiolytic agents. The primary aim of our study was to examine if of changes in skin resistance after placebo pre-screening can be used for objective assessment of an anxiolytic effect of drugs compared to commonly used subjective scales like Ramsay sedation scale (RSS), or The Richmond Agitation-Sedation Scale (RASS) and Observer's Assessment of Alertness and Sedation scale(OAASS). The secondary aim was to evaluate if changes of skin resistance can be used for assessing recovery from anaesthesia.

Patients The study was performed in adult patients scheduled for knee arthroscopy or minor plastic surgery under general anaesthesia. Consent was obtained the day before surgery during pre-anaesthetic visit. Exclusion criteria were previous history of taking drugs affecting mental functions, history of psychic illness, implanted electrical device, know allergy to benzodiazepines, myasthenia gravis, ASA classification ASA 3 and more. All patients consented not to use any medication for sedation or anxiety, opioid analgesics, ethanol and illicit drugs 24 hours before surgery. Patients were instructed that they will be administered by a random order first sedative agent or placebo and will be observed for their level of sedation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Placebo of the same volume and colour as active substance

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients scheduled for knee arthroscopy or minor plastic surgery under general anaesthesia

排除标准

  • previous history of taking drugs affecting mental functions, history of psychic illness, implanted electrical device, know allergy to benzodiazepines, myasthenia gravis, ASA classification ASA 3 and more. All patients consented not to use any medication for sedation or anxiety, opioid analgesics, ethanol and illicit drugs 24 hours before surgery.

研究组 & 干预措施

Control

Placebo Comparator

Normal saline 5 ml was administered 10 min. after insertion of intravenous cannula IV..

干预措施: Midazolam (Drug)

Midazolam

Experimental

Midazolam 2 mg was administered 5 min. after placebo and 5 min. before inducton to general anaesthesia IV.

干预措施: Midazolam (Drug)

结局指标

主要结局

Changes of skin resistence (percent from base-line values measured in ohms) during sedation

时间窗: 10 min. before administration and 5 min. after administration of midazolam (total 15 min.)

Investigation how far measurements of skin resistance can help determine level of sedation induced by intravenous midazolam

次要结局

  • Changes of skin resistence (percent from base-line values and values before termination of inhalational agent administration measured in ohms) during recovery from anaesthesia(From termination of inhalational agent administration till recovery to verbal comunication (expected time max. 15 min))

研究者

发起方
Charles University, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiri Malek

Assoc. Prfo. Jiri Malek, CSc.

Charles University, Czech Republic

研究点 (1)

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