ClinicalTrials.gov
ClinicalTrials.gov Menu

Audiovisual Distraction for Patients Undergoing Total Knee or Hip Replacement Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03191838
Recruitment Status : Recruiting
First Posted : June 19, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
University of Utah

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.

Condition or disease Intervention/treatment Phase
Anesthesia Other: Audiovisual Distraction Not Applicable

Detailed Description:

The perioperative period is often anxiety-provoking experience for many of our patients. Pain and awareness are the two primary concerns voiced most frequently. For total knee and hip replacement surgery, we offer our patients a spinal anesthetic which produces complete sensory blockade below the level of the waist. Despite a completely insensate knee or hip, patients still desire sedation during the surgery in order to remain unaware of their surgical surroundings. Propofol is commonly used in these monitored anesthesia care procedures because of its favorable drug profile. However, we have observed that anesthesia providers often use high infusion rates of propofol in order to achieve 'adequate patient comfort'. In this scenario, providers are often left with the dilemma of providing deeper levels of sedation for a pleasant patient experience and dealing with the potential cardiorespiratory complications that follow from oversedation. Unwanted side-effects include respiratory depression, airway obstruction and hypotension. Clinicians have began looking for other non-pharmacological ways to provide safe anxiolysis in the operating room while avoiding these undesirable side-effects.

Previous studies have shown that audiovisual distraction (AVD) can reduce stress and anxiety during the perioperative period. In 1997, Ganapathy et al. examined the use of sedative medications in elderly patients undergoing orthopedic procedures under spinal anesthesia. They compared patient-controlled propofol administration and anesthesiologist-controlled midazolam and fentanyl administration.This study found that there were no differences in patient satisfaction between the two groups. The secondary outcomes did show that propofol consumption was associated with significantly more episodes of brief respiratory rate depression but did not increase the need for emergency airway interventions.1

Ayoub et al studied propofol consumption in patients undergoing orthopedic procedures under spinal anesthesia using auditory distraction. This study demonstrated that auditory distraction decreased the amount of propofol consumed in patients using auditory distraction compared to those who had propofol sedation alone.2

Lee et al. began to shift the paradigm of medication induced anxiolysis and pain control during painful procedures through a series of studies examining different forms of distraction. An initial study conducted by this group confirmed that audio distraction during stimulating procedures (colonscopies) reduced the amount of propofol required. In 2003, they combined audio and visual distraction in patients undergoing and compared the dosages of propofol required to patients having only visual distraction or no distraction. This study found that patients with both audio and visual distraction required significantly less propofol than patients receiving visual distraction or patient-controlled sedation alone. Other key findings in the AVD group included reduced procedure time, a greater willingness by the patient to repeat the procedure under the same circumstances, and a statistically significant higher satisfaction score with the process.3

None of these studies has attempted to evaluate a possible reduction in propofol consumption for patients having a spinal anesthetic with both audio and visual distraction. We believe the next step to improving the perioperative experience for our patients is to incorporate AVD for patients having total knee and hip replacement surgery under a spinal anesthetic. Our hypothesis is that AVD will significantly reduce standard of care administered propofol consumption while still providing a pleasant experience for our patients and reducing unwanted side-effects associated with higher levels of propofol sedation.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Audiovisual Distraction Versus Propofol Sedation for Patients Undergoing Total Knee or Hip Replacement Surgery Under Spinal Anesthesia
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
Experimental: Audiovisual
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
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.

No Intervention: Controls
The control group will not be given distraction equipment.



Primary Outcome Measures :
  1. Propofol Consumption [ Time Frame: Intra-operative drug use ]
    Comparison of AV distraction patients and control group propofol consumption (micrograms/kilograms/minute) during surgery


Secondary Outcome Measures :
  1. Movement [ Time Frame: continuously monitored during surgery every fifteen minutes ]
    Graded movement during surgery using a validated movement scale graded 0-3 with 0 being no movement and 3 being surgery difficult to perform

  2. Satisfaction with Anesthesia [ Time Frame: Post-operatively obtained directly following admission to a phase II anesthesia care unit ]
    Iowa Satisfaction with Anesthesia score, a validated assessment of patient reported undesirable effects from surgery and if they would have the same anesthetic in future surgeries

  3. provider-involved airway interventions [ Time Frame: continuously monitored during surgery ]
    The number and timing of provider-involved airway interventions including replacement of nasal cannula with facemask, placement of oral or nasal airway, or endotracheal intubation will be recorded

  4. hypotensive episodes [ Time Frame: continuously monitored during surgery ]
    hypotensive episodes including SPB less than 90

  5. oxygen desaturation episodes [ Time Frame: continuously monitored during surgery ]
    oxygen desaturation episodes including SPO2 less than 90



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191838


Contacts
Contact: Ami Stuart, PhD 8015816393 ami.stuart@hsc.utah.edu

Locations
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Ami Stuart, PhD    801-581-6393    ami.stuart@hsc.utah.edu   
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Adam Meier, DO University of Utah

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT03191838     History of Changes
Other Study ID Numbers: 102391
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared with other researchers

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No