Clinical trial NCT03055663: Sedation Using Virtual Reality During Surgery Under Spinal Anesthesia
Official title: A Comparison of Patient Satisfaction Between Sedation Using Medication and Sedation Using Virtual Reality During Surgery Under Spinal Anesthesia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedation
Spinal Anesthesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-02-16
Enrollment: 37
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized controlled trial
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
measure: Satisfaction score of patient
timeFrame: 20 minutes after the arrival at the postanesthesia care unit
Secondary outcomes:
measure: Satisfaction score of surgeon
timeFrame: 5 minutes after the end of the main surgical procedure
measure: Satisfaction score of anesthesiologist
timeFrame: 5 minutes after the end of the surgery
measure: incidence of adequate sedation
timeFrame: 5 minutes after the end of surgery
measure: incidence of desaturation
timeFrame: 5 min after the end of surgery
measure: incidence of apnea
timeFrame: 5 min after the end of surgery
measure: incidence of hypotension
timeFrame: 5 min after the end of surgery
measure: incidence of bradycardia
timeFrame: 5 min after the end of surgery
measure: incidence of rescue medication for sedation
timeFrame: 5 min after the end of surgery
measure: incidence of assisted mask ventilation
timeFrame: 5 min after the end of surgery
measure: incidence of nausea
timeFrame: 5 min after the end of surgery
measure: incidence of vomiting
timeFrame: 5 min after the end of surgery
measure: time to recovery at post-anesthesia care unit
timeFrame: 5 min after the stay in the post-anesthesia care unit
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: