Sedation Using Virtual Reality During Surgery Under Spinal Anesthesia

Not Applicable

Completed

• Conditions: Sedation; Spinal Anesthesia
• Interventions: Other: Sedation by watching virtual reality sedative program; Procedure: Sedation by using intravenous sedative; Drug: Midazolam

• Registration Number: NCT03055663
• Lead Sponsor: Seoul National University Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-02-14
• Study First Submitted QC: 2017-02-15
• Study First Posted: 2017-02-16
• Study Start: 2017-02-20
• Primary Completion: 2017-10-31
• Study Completion: 2017-10-31
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-01
• Last Update Posted: 2018-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual reality sedation	Sedation by watching virtual reality sedative program	Patients watches virtual reality sedation program that shows underwater world with comfortable music and narrations during surgery.
Sedation with intravenous sedatives	Sedation by using intravenous sedative	Patients receives intravenous sedative of midazolam (initial bolus 1-2 mg with maintenance dose of 1 mg every 10 - 30 min).
Sedation with intravenous sedatives	Midazolam	Patients receives intravenous sedative of midazolam (initial bolus 1-2 mg with maintenance dose of 1 mg every 10 - 30 min).

Primary Outcome Measures

Name	Time	Method
Satisfaction score of patient	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

Name	Time	Method
incidence of rescue medication for sedation	5 min after the end of surgery	incidence of rescue medication for sedation administered during the surgery
incidence of adequate sedation	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
incidence of hypotension	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
incidence of nausea	5 min after the end of surgery	incidence of nausea of numerical rating scale of more than 5 during the surgery
incidence of vomiting	5 min after the end of surgery	incidence of vomiting during the surgery
Satisfaction score of anesthesiologist	5 minutes after the end of the surgery	Anesthesiologist's satisfaction score measured by 5-point Likert-like verbal rating scale
Satisfaction score of surgeon	5 minutes after the end of the main surgical procedure	Surgeon's satisfaction score measured by 5-point Likert-like verbal rating scale
incidence of desaturation	5 min after the end of surgery	incidence of desaturation (pulse oximetry \<90% for more than 5 sec) during the surgery
incidence of bradycardia	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
incidence of assisted mask ventilation	5 min after the end of surgery	incidence of assisted mask ventilation due to prolonged apnea during the surgery
time to recovery at post-anesthesia care unit	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
incidence of apnea	5 min after the end of surgery	incidence of apnea (no detectable end-tidal carbon dioxide for more than 5 sec) during the surgery

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of