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Clinical Trials/NCT04873076
NCT04873076CompletedNot Applicable

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

University Hospital, Essen2 sites in 1 country70 target enrollmentStarted: November 20, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
70
Locations
2
Primary Endpoint
Change of analgosedation dosage

Study Overview

Brief Summary

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).

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patient undergoing catheter ablation for rhythm disorders

Exclusion Criteria

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

Outcomes

Primary Outcomes

Change of analgosedation dosage

Time Frame: 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

Time Frame: during the procedure (electrophysiological examination on the heart)

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

Secondary Outcomes

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

Investigators

Sponsor
University Hospital, Essen
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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