Sedation Using Virtual Reality During Surgery Under Spinal Anesthesia

Seoul National University Hospital37 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interventions

Sedation by watching virtual reality sedative programOTHER

Patients watch three-dimensional virtual reality program with headset and headphone during surgery.

Sedation by using intravenous sedativePROCEDURE

Patients receive intravenous sedative (midazolam 1-2 mg bolus with 1 mg maintenance dose every 10- 30 minutes)

MidazolamDRUG

Patients receive intravenous sedative (midazolam 1-2 mg bolus with 1 mg maintenance dose every 10- 30 minutes)

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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)

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Satisfaction score of patient

Patient's satisfaction score measured by 5-point Likert-like verbal rating scale

Time frame: 20 minutes after the arrival at the postanesthesia care unit

Secondary Outcomes

Satisfaction score of surgeon

Surgeon's satisfaction score measured by 5-point Likert-like verbal rating scale

Time frame: 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

Time frame: 5 minutes after the end of the surgery

incidence of adequate sedation

Adequate sedation is defined if all the following criteria met 1. patient does not complain discomfort or does not move arm or face unnecessarily or intend to remove the monitoring device or cable 2. patients lying still in a stable state 3. incidence of desaturation (\<95% for more than 5 sec) less than 2 (one or zero) during surgery 4. incidence of apnea (duration of more than 5 seconds) less than 2 during surgery 5. does not need mask ventilation or laryngeal mask insertion or endotracheal intubation 6. incidence of hypotension (mean blood pressure\<55 mmHg) or bradycardia (heart rate \<50) less than 2 during surgery 7. does not need propofol as a rescue sedative medication

Time frame: 5 minutes after the end of surgery

incidence of desaturation

incidence of desaturation (pulse oximetry \<90% for more than 5 sec) during the surgery