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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality sedation | Experimental | Patients watches virtual reality sedation program that shows underwater world with comfortable music and narrations during surgery. |
|
| Sedation with intravenous sedatives | Active Comparator | Patients receives intravenous sedative of midazolam (initial bolus 1-2 mg with maintenance dose of 1 mg every 10 - 30 min). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sedation by watching virtual reality sedative program | Other | Patients watch three-dimensional virtual reality program with headset and headphone during surgery. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Prospective, randomized controlled trial
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Open-labelled
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| 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) |
|
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
| 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 |
| D006571 | Heterocyclic Compounds |