drugset / Trial / NCT02506673

Audiovisual Aid Pilot Study

NCT02506673 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

Little is known about perioperative stress responses and possible anxiety mitigating factors like audiovisual aids or IV sedation. Most studies use surrogate markers and retrospective questionnaires, and are not based on real-time gathered data. Skin conductance measurements allow the sympathetic discharge to be evaluated down to fractions of a second and enable us to continuously monitor stress responses as skin conductance responses/per second during the perioperative management. In our study, the investigators propose to examine the effect of personal audiovisual equipment (audio/video goggles) on perioperative stress, pain, and overall experience in patients undergoing ambulatory meniscectomy under spinal anesthesia. Patients will be randomly assigned to either receive traditional sedation or light sedation in addition to audiovisual equipment. The investigators hope to determine outcome estimates of the use of this equipment on stress levels using skin conductance measurements, request for further sedation, postoperative pain levels and analgesic consumption, time to discharge readiness, and overall patient satisfaction, and collect thus far unavailable data on the stress response to perioperative stresses (such as IV insertion and spinal placement) in order to allow for power analyses for future studies.

Timeline

Start
2016-01-14
Primary completion
2017-05
Completion
2017-07

Drugs

EvaluationDrugModalityDoseRoute
Background Midazolam Small molecule 2 mg —

Indications

No indication recorded.