Audiovisual Distraction for Patients Undergoing Total Knee or Hip Replacement Surgery

NCT03191838 | Completed DMC

• 1 other identifier: 102391
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to investigate whether audiovisual distraction can lead to a reduction in standard of care administered intraoperative propofol consumption compared to those who receive propofol sedation alone in adults having total hip or knee replacement surgery under spinal anesthesia.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Propofol Consumption

  Comparison of AV distraction patients and control group propofol consumption (micrograms/kilograms/minute) during surgery

  Intra-operative drug use

Secondary Outcomes (5)

• Movement

  continuously monitored during surgery every fifteen minutes

• Satisfaction with Anesthesia

  Post-operatively obtained directly following admission to a phase II anesthesia care unit

• provider-involved airway interventions

  continuously monitored during surgery

• hypotensive episodes

  continuously monitored during surgery

• oxygen desaturation episodes

  continuously monitored during surgery

Study Arms (2)

Audiovisual

EXPERIMENTAL

The interventional group will be given audiovisual equipment. An Apple iPad will be attached to a Mayo stand and placed approximately 12-15 inches from the patient's face. Noise canceling headphones will be connected to the iPad. A movie of the subject's choosing will be shown on the iPad with a comfortable level of sound.

Other: Audiovisual Distraction

Controls

NO INTERVENTION

The control group will not be given distraction equipment.

Interventions

Audiovisual Distraction OTHER

The interventional group will be given audiovisual equipment. An Apple iPad will be attached to a Mayo stand and placed approximately 12-15 inches from the patient's face. Noise canceling headphones will be connected to the iPad. A movie of the subject's choosing will be shown on the iPad with a comfortable level of sound.

Audiovisual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults \>18 years of age having a
• Primary total hip or knee arthroplasty
• Surgery under a spinal anesthetic

You may not qualify if:

• ASA status \>3
• parturients
• documented hearing or vision loss
• chronic opioid use (\>30mg PO MEQ daily for \>1 month)
• diagnosis of OSA, contraindications to spinal (coagulopathy, infection, spinal hardware)
• non-English speaking
• current history of substance abuse
• schizophrenia
• generalized anxiety disorder
• Alzheimer's disease
• other dementia

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Study Officials

• Adam Meier, DO

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 19, 2017
• Study Start: November 1, 2017
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)