New York, New York 10021


Purpose:

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.


Study summary:

PLEASE NOTE: After conducting the interim analysis and plotting the skin conductance data, we have determined that the graphs are not consistent enough to draw any conclusions. Given the technical difficulties we have encountered with the Med-Storm Stress Detector, as well as the labor intensity associated with it, we have decided that we will no longer use it from patient 14 on. We will not mark the time points and hand movements described in the protocol, as this data was used to understand the skin conductance data. We will continue to enroll patients to complete this pilot/exploratory study, as the other secondary outcomes--in particular, the surveys--could provide valuable information.


Criteria:

Inclusion Criteria: - Patients scheduled for primary, ambulatory, arthroscopic meniscectomy under spinal anesthesia Exclusion Criteria: - Patients with psychiatric disease and those on antidepressants - Contraindications to spinal anesthesia or allergy to study medication - Age < 18 years - Patients with audiovisual impairments - Patients with inability to communicate in English or understand the study requirements - Chronic pain patients +/- opioid use - Patients with (neuro)dermatoses encompassing the hand - Patients with pacemakers - Patients with diabetes or known neuropathic disease - Patients with a history of epilepsy or seizure disorder - Patients with a history of claustrophobia - Patients with a history of epilepsy - Patients with prior history of epilepsy or seizure disorder - Patients undergoing a revision or open procedure


NCT ID:

NCT02506673


Primary Contact:

Principal Investigator
Stavros G. Memtsoudis, MD, PhD
Hospital for Special Surgery, New York

Katherine L. Lee, BA
Phone: 646-797-8948 ext. 8948
Email: LeeK@hss.edu


Backup Contact:

Email: MancenidoD@hss.edu
Denesy Mancenido, BA
Phone: 212-774-2602 ext. 2602


Location Contact:

New York, New York 10021
United States

Katherine L. Lee, BA
Phone: 646-797-8948
Email: leeK@hss.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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