Sedation Using Virtual Reality During Surgery Under Spinal Anesthesia

NCT03055663 | Completed

• 1 other identifier: 1611-069-808
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation; Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Satisfaction score of surgeon

  5 minutes after the end of the main surgical procedure

• Satisfaction score of anesthesiologist

  5 minutes after the end of the surgery

• incidence of adequate sedation

  5 minutes after the end of surgery

• incidence of desaturation

  5 min after the end of surgery

• incidence of apnea

  5 min after the end of surgery

Study Arms (2)

Virtual reality sedation

EXPERIMENTAL

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

Sedation with intravenous sedatives

ACTIVE COMPARATOR

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; Drug: Midazolam

Interventions

Sedation by watching virtual reality sedative program OTHER

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

Virtual reality sedation

Sedation by using intravenous sedative PROCEDURE

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

Sedation with intravenous sedatives

Midazolam DRUG

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

Sedation with intravenous sedatives

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-labelled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Prospective, randomized controlled trial

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 16, 2017
• Study Start: February 20, 2017
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2017
• Last Updated: April 3, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)