Sedation Using Virtual Reality During Surgery Under Spinal Anesthesia

Overview

During spinal anesthesia, sedation is performed using intravenous sedative for the patient's comfort and appropriate surgical environment. However, side effects of medications such as respiratory depression, hypotension, bradycardia and desaturation cannot be avoided. Recently, there have been developed a virtual reality experience equipment and a variety of virtual reality programs including visuo-haptic computer technology. There have been clinical studies that apply this technology to the pain medicine, sedation and medical education. However, no study has been reported for the purpose of replacing sedation during spinal anesthesia. Therefore, we attempt to evaluate the efficacy and safety of sedation using virtual reality meditation program during spinal anesthesia for urologic surgery.

Full Title of Study: “A Comparison of Patient Satisfaction Between Sedation Using Medication and Sedation Using Virtual Reality During Surgery Under Spinal Anesthesia: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 31, 2017

Detailed Description

During spinal anesthesia, sedation is performed using intravenous sedative for the patient's comfort and appropriate surgical environment. However, side effects of medications such as respiratory depression, hypotension, bradycardia and desaturation cannot be avoided. Recently, there have been developed a virtual reality experience equipment and a variety of virtual reality programs including visuo-haptic computer technology. There have been clinical studies that apply this technology to the pain medicine, sedation and medical education. However, no study has been reported for the purpose of replacing sedation during spinal anesthesia. Therefore, we attempt to evaluate the efficacy and safety of sedation using virtual reality meditation program during spinal anesthesia for urologic surgery.

Interventions

  • Other: Sedation by watching virtual reality sedative program
    • Patients watch three-dimensional virtual reality program with headset and headphone during surgery.
  • Procedure: Sedation by using intravenous sedative
    • Patients receive intravenous sedative (midazolam 1-2 mg bolus with 1 mg maintenance dose every 10- 30 minutes)
  • Drug: Midazolam
    • Patients receive intravenous sedative (midazolam 1-2 mg bolus with 1 mg maintenance dose every 10- 30 minutes)

Arms, Groups and Cohorts

  • Experimental: Virtual reality sedation
    • Patients watches virtual reality sedation program that shows underwater world with comfortable music and narrations during surgery.
  • Active Comparator: Sedation with intravenous sedatives
    • Patients receives intravenous sedative of midazolam (initial bolus 1-2 mg with maintenance dose of 1 mg every 10 – 30 min).

Clinical Trial Outcome Measures

Primary Measures

  • Satisfaction score of patient
    • Time Frame: 20 minutes after the arrival at the postanesthesia care unit
    • Patient’s satisfaction score measured by 5-point Likert-like verbal rating scale

Secondary Measures

  • Satisfaction score of surgeon
    • Time Frame: 5 minutes after the end of the main surgical procedure
    • Surgeon’s satisfaction score measured by 5-point Likert-like verbal rating scale
  • Satisfaction score of anesthesiologist
    • Time Frame: 5 minutes after the end of the surgery
    • Anesthesiologist’s satisfaction score measured by 5-point Likert-like verbal rating scale
  • incidence of adequate sedation
    • Time Frame: 5 minutes after the end of surgery
    • Adequate sedation is defined if all the following criteria met patient does not complain discomfort or does not move arm or face unnecessarily or intend to remove the monitoring device or cable patients lying still in a stable state incidence of desaturation (<95% for more than 5 sec) less than 2 (one or zero) during surgery incidence of apnea (duration of more than 5 seconds) less than 2 during surgery does not need mask ventilation or laryngeal mask insertion or endotracheal intubation incidence of hypotension (mean blood pressure<55 mmHg) or bradycardia (heart rate <50) less than 2 during surgery does not need propofol as a rescue sedative medication
  • incidence of desaturation
    • Time Frame: 5 min after the end of surgery
    • incidence of desaturation (pulse oximetry <90% for more than 5 sec) during the surgery
  • incidence of apnea
    • Time Frame: 5 min after the end of surgery
    • incidence of apnea (no detectable end-tidal carbon dioxide for more than 5 sec) during the surgery
  • incidence of hypotension
    • Time Frame: 5 min after the end of surgery
    • incidence of hypotension (decrease in mean blood pressure of more than 30% of baseline or mean blood pressure less than 55 mmHg) during the surgery
  • incidence of bradycardia
    • Time Frame: 5 min after the end of surgery
    • incidence of bradycardia (decrease in heart rate of more than 30% of baseline or heart rate fall below 50 beats/min
  • incidence of rescue medication for sedation
    • Time Frame: 5 min after the end of surgery
    • incidence of rescue medication for sedation administered during the surgery
  • incidence of assisted mask ventilation
    • Time Frame: 5 min after the end of surgery
    • incidence of assisted mask ventilation due to prolonged apnea during the surgery
  • incidence of nausea
    • Time Frame: 5 min after the end of surgery
    • incidence of nausea of numerical rating scale of more than 5 during the surgery
  • incidence of vomiting
    • Time Frame: 5 min after the end of surgery
    • incidence of vomiting during the surgery
  • time to recovery at post-anesthesia care unit
    • Time Frame: 5 min after the stay in the post-anesthesia care unit
    • time to report the modified Aldrete score of 9 or more at post-anesthesia care unit

Participating in This Clinical Trial

Inclusion Criteria

  • Patients undergoing spinal anesthesia for urologic surgeries including Holmium Laser Enucleation of the Prostate or TransUrethral Resection of Bladder tumor). – American Society of Anesthesiologists physical status classification 1, 2 or 3. – Patients who voluntarily decides to participate in the trial and has given informed consent to this trial Exclusion Criteria:

  • History of chronic use of sedative, narcotics, alcohol or drug abuse – Baseline oxygen saturation < 90% – Baseline hemodynamic or respiratory instability (initial systolic blood pressure < 80 mmHg, respiratory rate > 25 breaths/min or < 10 breaths/min)

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Won Ho Kim, MD, Clinical Associate Professor – Seoul National University Hospital

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