A Comparison of Patient Satisfaction Between Sedation Using Medication and Sedation Using Virtual Reality During Surgery Under Spinal Anesthesia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Satisfaction score of patient
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open-labelled
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Virtual reality sedation
Patients watches virtual reality sedation program that shows underwater world with comfortable music and narrations during surgery.
干预措施: Sedation by watching virtual reality sedative program (Other)
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).
干预措施: Sedation by using intravenous sedative (Procedure)
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).
干预措施: Midazolam (Drug)
结局指标
主要结局
Satisfaction score of patient
时间窗: 20 minutes after the arrival at the postanesthesia care unit
Patient's satisfaction score measured by 5-point Likert-like verbal rating scale
次要结局
- 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)
研究者
Won Ho Kim, MD
Clinical Associate Professor
Seoul National University Hospital