Sedation Using Virtual Reality During Surgery Under Spinal Anesthesia

Sedation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055663
• Other study ID #: 1611-069-808
• Status: Completed
• Phase: N/A
• First received: February 14, 2017
• Last updated: April 1, 2018
• Start date: February 20, 2017
• Est. completion date: October 31, 2017

Study information

• Verified date: April 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Sedation
• Spinal Anesthesia

Intervention

Other:
• Sedation by watching virtual reality sedative program
Patients watch three-dimensional virtual reality program with headset and headphone during surgery.

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)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	incidence of desaturation	incidence of desaturation (pulse oximetry <90% for more than 5 sec) during the surgery	5 min after the end of surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	incidence of rescue medication for sedation	incidence of rescue medication for sedation administered during the surgery	5 min after the end of surgery
Secondary	incidence of assisted mask ventilation	incidence of assisted mask ventilation due to prolonged apnea during the surgery	5 min after the end of surgery
Secondary	incidence of nausea	incidence of nausea of numerical rating scale of more than 5 during the surgery	5 min after the end of surgery
Secondary	incidence of vomiting	incidence of vomiting during the surgery	5 min after the end of surgery
Secondary	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