About this trial
One treatment option of internal carotid artery stenosis is open surgical endarterectomy. The operation is frequently carried out under regional plexus anesthesia, allowing the patient to remain awake during the procedure. This approach offers the advantage of monitoring for neurological changes during carotid artery clamping, allowing the surgical team to immediately respond by placing a shunt to ensure cerebral perfusion. As a result, performing surgery under regional anesthesia provides therefor a benefit. However, for patients, the procedure, which can last up to two hours or longer in some cases, may pose a significant burden. The fixed position, inability to move, sterile drapes over the face, manipulation by the surgical team, and anxiety about potential complications are just a few of the factors that may distress patients during the operation. Increased sweating and reports of substantial subjective distress are not uncommon if the procedure is performed under local anesthesia.
In many medical fields, devices and therapies are now being utilized to reduce patient stress in the perioperative setting. In procedures performed under local or regional anesthesia, such as in orthopedics or dentistry, efforts are being made to make operations more tolerable and less stressful for patients. For example, music and video goggles are employed to entertain and distract patients during the intervention. Newer approaches using video googles appear in more and more fields to reduce distress. Especially in vascular surgery and particularly in carotid surgery, the use of audiovisual distraction during the procedure has not been implemented to our knowledge, and its benefits remain undocumented. Because of the special setting and burden for the patients it is highly necessary to test these devices in carotid surgery and explore potential benefits for these patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Planed carotid endarterectomy in local anesthesia
Disqualifiers
patients which are not able to communicate because of stroke or language barrier,
Dementia or neurological damage which impairs answering questionnaires or the understanding of the situation during surgery
medication with steroids
Trial design
Parallel
Treatments tested in this trial
video googles
DevicePatients undergoing surgery use video googles and a headphone to distract from surgery
Treatment groups
Trial outcomes
Primary outcomes
Bloodserum cortisol levels
cortisol levels in the blood are measured on six specific times in the perioperative setting
Heartrate
The heart rate is measured on six specific times in the perioperative setting
short questionnaire on current stress
The short questionnaire on current stress; is measured on six specific times in the perioperative setting. It is a validated score to measure actual stress, there are 6 items, with 6 a scale one to six. The minimal score is 6 (low distress) and 36 (high distress)
Richmond Agitation-Sedation Scale (RASS)
TheRichmond Agitation-Sedation Scale (RASS) is measured on six specific times in the perioperative setting. It is a score typically used in anesthesia to measure agitation and sedation. The scale is from +4 (aggressive) over 0 (awake and calm) to -5 (deeply sleeping, not awakable)
Sponsors and contacts
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University Hospital Augsburg
Lead sponsor
HappyMed GmbH (Wien, Austria)
Collaborator