Sedation Using Virtual Reality During Surgery Under Spinal Anesthesia

A Comparison of Patient Satisfaction Between Sedation Using Medication and Sedation Using Virtual Reality During Surgery Under Spinal Anesthesia: A Randomized Controlled Trial

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 Overview

• Status: Completed
• Conditions: Spinal Anesthesia; Sedation
• Intervention / Treatment: Other: Sedation by watching virtual reality sedative program; Procedure: Sedation by using intravenous sedative; Drug: Midazolam

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.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual reality sedation; Patients watches virtual reality sedation program that shows underwater world with comfortable music and narrations during surgery.	Other: Sedation by watching virtual reality sedative program; Patients watch three-dimensional virtual reality program with headset and headphone during surgery.
Active Comparator: 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).	Procedure: Sedation by using intravenous sedative; Patients receive intravenous sedative (midazolam 1-2 mg bolus with 1 mg maintenance dose every 10- 30 minutes); Drug: Midazolam; Patients receive intravenous sedative (midazolam 1-2 mg bolus with 1 mg maintenance dose every 10- 30 minutes)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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; patient does not complain discomfort or does not move arm or face unnecessarily or intend to remove the monitoring device or cable; patients lying still in a stable state; incidence of desaturation (<95% for more than 5 sec) less than 2 (one or zero) during surgery; incidence of apnea (duration of more than 5 seconds) less than 2 during surgery; does not need mask ventilation or laryngeal mask insertion or endotracheal intubation; incidence of hypotension (mean blood pressure<55 mmHg) or bradycardia (heart rate <50) less than 2 during surgery; does not need propofol as a rescue sedative medication	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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2017
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): October 31, 2017

Study Registration Dates

• First Submitted: February 14, 2017
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (Actual): February 16, 2017

Study Record Updates

• Last Update Posted (Actual): April 3, 2018
• Last Update Submitted That Met QC Criteria: April 1, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Hypnotics and Sedatives
• Other Study ID Numbers: 1611-069-808

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No