跳至主要内容
临床试验/NCT04873076
NCT04873076已完成不适用

Change of Analgosedation (Remifentanil) Dosage and Increased Patient Satisfaction During Catheter Ablation Procedures in Cardiac Rhythm Disorders Via 2d Audiovisual Distraction.

University Hospital, Essen2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
2
主要终点
Change of analgosedation dosage

研究概览

简要总结

In this randomized controlled trial, amount of sedation exposure and patient satisfaction is evaluated in patients undergoing catheter ablation for rhythm disorders via an audiovisual distraction. Patients are randomized into intervention group (adiovisual distraction) or controll (no intervention).

详细描述

Study conduct:

After the patient has been informed and given written consent to participate in the study, the patients are randomized. They are either assigned to the control group (in which catheter ablation will take place without video glasses as before) or to the intervention group in which they receive the video glasses during ablation. The randomization into the two groups is done by random allocation.

The patients in the intervention group receive instruction on how to use the video glasses and can familiarize themselves with them. Before the patient (as well in the intervention as in the control group) is taken to the EPU laboratory, he receives the first questionnaire in which the personal data and his mood / feeling of fear are collected. In addition, two questions on instrumental-qualification media studies should give an indication of possible relationships between the evaluation of video glasses. The patient is then led into the laboratory and connected to the monitoring by the team. Before it is covered under sterile conditions, the patients in the intervention group receive the glasses and remote control with which they can select the footage from the media library.

The anesthetist will inject a basic dose of sedative and analgesic (determined on the basis of body weight) into each patient and increase it if pain or agitation is noticeable. All patients receive their individual dosage to ensure painless ablation. During the examination, the vital parameters (blood pressure and heart rate) are documented at specified times.

After completing catheter ablation, the video glasses (for patients from the intervention group) are removed. The patients receive a second questionnaire in which they evaluate the use of the video glasses.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

  • Patient undergoing catheter ablation for rhythm disorders

排除标准

  • age <18 years
  • visus <-5 dpt or >+2 dpt

结局指标

主要结局

Change of analgosedation dosage

时间窗: during the procedure (electrophysiological examination on the heart)

The change of analgosedation dose is measured by comparing the amount of sedation necessary for the procedure in experimental and controll arm. Remifentanyl (Ultiva) is measured in µg/kg/hour Midazolam (Dormicum) is measured in mg/kg/hour

Change of stress and anxiety level

时间窗: during the procedure (electrophysiological examination on the heart)

The vital parameter blood pressure (in mmHg) serve as surrogate parameter for anxiety and stress.

次要结局

  • Patient satisfaction(evaluation before, immediately after and one day after the procedure)

研究者

发起方
University Hospital, Essen
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验