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NCT Number: NCT03055663

Sedation Using Virtual Reality During Surgery Under Spinal Anesthesia

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.

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Key information

Conditions

Sedation Spinal Anesthesia

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sedation by watching virtual reality sedative program

Other

Patients watch three-dimensional virtual reality program with headset and headphone during surgery.

Sedation by using intravenous sedative

Procedure

Patients receive intravenous sedative (midazolam 1-2 mg bolus with 1 mg maintenance dose every 10- 30 minutes)

midazolam

Drug

Patients receive intravenous sedative (midazolam 1-2 mg bolus with 1 mg maintenance dose every 10- 30 minutes)

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. incidence of vomiting

    Time frame: 5 min after the end of surgery

    incidence of vomiting during the surgery

  12. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 16, 2017
Registry last updated
Apr 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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