Sedation Using Virtual Reality During Surgery Under Spinal Anesthesia

• ClinicalTrials.gov Identifier: NCT03055663
• Recruitment Status: Completed
• First Posted: February 16, 2017
• Last Update Posted: April 3, 2018
• Sponsor: Seoul National University Hospital
• Information provided by (Responsible Party): Won Ho Kim, MD, Seoul National University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sedation; Spinal Anesthesia	Other: Sedation by watching virtual reality sedative program; Procedure: Sedation by using intravenous sedative; Drug: Midazolam	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective, randomized controlled trial
• Masking: None (Open Label)
• Masking Description: Open-labelled
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: February 20, 2017
• Actual Primary Completion Date: October 31, 2017
• Actual Study Completion Date: October 31, 2017

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. Satisfaction score of patient [ Time Frame: 20 minutes after the arrival at the postanesthesia care unit ]
   Patient's satisfaction score measured by 5-point Likert-like verbal rating scale

Secondary Outcome Measures :

1. Satisfaction score of surgeon [ Time Frame: 5 minutes after the end of the main surgical procedure ]
   Surgeon's satisfaction score measured by 5-point Likert-like verbal rating scale
2. Satisfaction score of anesthesiologist [ Time Frame: 5 minutes after the end of the surgery ]
   Anesthesiologist's satisfaction score measured by 5-point Likert-like verbal rating scale
3. incidence of adequate sedation [ Time Frame: 5 minutes after the end of surgery ]

   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
4. incidence of desaturation [ Time Frame: 5 min after the end of surgery ]
   incidence of desaturation (pulse oximetry <90% for more than 5 sec) during the surgery
5. incidence of apnea [ Time Frame: 5 min after the end of surgery ]
   incidence of apnea (no detectable end-tidal carbon dioxide for more than 5 sec) during the surgery
6. incidence of hypotension [ Time Frame: 5 min after the end of surgery ]
   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
7. incidence of bradycardia [ Time Frame: 5 min after the end of surgery ]
   incidence of bradycardia (decrease in heart rate of more than 30% of baseline or heart rate fall below 50 beats/min
8. incidence of rescue medication for sedation [ Time Frame: 5 min after the end of surgery ]
   incidence of rescue medication for sedation administered during the surgery
9. incidence of assisted mask ventilation [ Time Frame: 5 min after the end of surgery ]
   incidence of assisted mask ventilation due to prolonged apnea during the surgery
10. incidence of nausea [ Time Frame: 5 min after the end of surgery ]
    incidence of nausea of numerical rating scale of more than 5 during the surgery
11. incidence of vomiting [ Time Frame: 5 min after the end of surgery ]
    incidence of vomiting during the surgery
12. time to recovery at post-anesthesia care unit [ Time Frame: 5 min after the stay in the post-anesthesia care unit ]
    time to report the modified Aldrete score of 9 or more at post-anesthesia care unit

Eligibility Criteria

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

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)

Contacts and Locations

Locations

Korea, Republic of

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Sponsors and Collaborators

Seoul National University Hospital

More Information

• Responsible Party: Won Ho Kim, MD, Clinical Associate Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT03055663
• Other Study ID Numbers: 1611-069-808
• First Posted: February 16, 2017
• Last Update Posted: April 3, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Midazolam; Hypnotics and Sedatives; Adjuvants, Anesthesia; Central Nervous System Depressants; Physiological Effects of Drugs; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; GABA Modulators; GABA Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action