Sedation Using Virtual Reality During Surgery Under Spinal Anesthesia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Sedation, Spinal Anesthesia

Intervention / Treatment
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* Other: Sedation by watching virtual reality sedative program
* Procedure: Sedation by using intravenous sedative
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality sedation<br>Patients watches virtual reality sedation program that shows underwater world with comfortable music and narrations during surgery. | Other: Sedation by watching virtual reality sedative program<br>* Patients watch three-dimensional virtual reality program with headset and headphone during surgery.<br>|
| Active Comparator: Sedation with intravenous sedatives<br>Patients receives intravenous sedative of midazolam (initial bolus 1-2 mg with maintenance dose of 1 mg every 10 - 30 min). | Procedure: Sedation by using intravenous sedative<br>* Patients receive intravenous sedative (midazolam 1-2 mg bolus with 1 mg maintenance dose every 10- 30 minutes)<br>Drug: Midazolam<br>* Patients receive intravenous sedative (midazolam 1-2 mg bolus with 1 mg maintenance dose every 10- 30 minutes)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction score of patient | Patient's satisfaction score measured by 5-point Likert-like verbal rating scale | 20 minutes after the arrival at the postanesthesia care unit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction score of surgeon | Surgeon's satisfaction score measured by 5-point Likert-like verbal rating scale | 5 minutes after the end of the main surgical procedure | 
| Satisfaction score of anesthesiologist | Anesthesiologist's satisfaction score measured by 5-point Likert-like verbal rating scale | 5 minutes after the end of the surgery | 
| incidence of adequate sedation | 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 | 5 minutes after the end of surgery | 
| incidence of desaturation | incidence of desaturation (pulse oximetry <90% for more than 5 sec) during the surgery | 5 min after the end of surgery | 
| incidence of apnea | incidence of apnea (no detectable end-tidal carbon dioxide for more than 5 sec) during the surgery | 5 min after the end of surgery | 
| incidence of hypotension | 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 | 5 min after the end of surgery | 
| incidence of bradycardia | incidence of bradycardia (decrease in heart rate of more than 30% of baseline or heart rate fall below 50 beats/min | 5 min after the end of surgery | 
| incidence of rescue medication for sedation | incidence of rescue medication for sedation administered during the surgery | 5 min after the end of surgery | 
| incidence of assisted mask ventilation | incidence of assisted mask ventilation due to prolonged apnea during the surgery | 5 min after the end of surgery | 
| incidence of nausea | incidence of nausea of numerical rating scale of more than 5 during the surgery | 5 min after the end of surgery | 
| incidence of vomiting | incidence of vomiting during the surgery | 5 min after the end of surgery | 
| time to recovery at post-anesthesia care unit | time to report the modified Aldrete score of 9 or more at post-anesthesia care unit | 5 min after the stay in the post-anesthesia care unit |