A Comparison of Patient Satisfaction Between Sedation Using Medication and Sedation Using Virtual Reality During Surgery Under Spinal Anesthesia: A Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Sedation by watching virtual reality sedative program
- Conditions
- Sedation
- Sponsor
- Seoul National University Hospital
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Satisfaction score of patient
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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
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.
Investigators
Won Ho Kim, MD
Clinical Associate Professor
Seoul National University Hospital
Eligibility Criteria
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
- •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)
Arms & Interventions
Virtual reality sedation
Patients watches virtual reality sedation program that shows underwater world with comfortable music and narrations during surgery.
Intervention: Sedation by watching virtual reality sedative program
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).
Intervention: Sedation by using intravenous sedative
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).
Intervention: Midazolam
Outcomes
Primary Outcomes
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
- incidence of rescue medication for sedation(5 min after the end of surgery)
- incidence of adequate sedation(5 minutes after the end of surgery)
- incidence of hypotension(5 min after the end of surgery)
- incidence of nausea(5 min after the end of surgery)
- incidence of vomiting(5 min after the end of surgery)
- Satisfaction score of anesthesiologist(5 minutes after the end of the surgery)
- Satisfaction score of surgeon(5 minutes after the end of the main surgical procedure)
- incidence of desaturation(5 min after the end of surgery)
- incidence of bradycardia(5 min after the end of surgery)
- incidence of assisted mask ventilation(5 min after the end of surgery)
- time to recovery at post-anesthesia care unit(5 min after the stay in the post-anesthesia care unit)
- incidence of apnea(5 min after the end of surgery)