Sedation Using Virtual Reality During Surgery Under Spinal Anesthesia

Seoul National University

Status: Completed

Conditions: Spinal Anesthesia; Sedation

Treatments: Drug: Midazolam; Other: Sedation by watching virtual reality sedative program; Procedure: Sedation by using intravenous sedative

Study type: Interventional

Funder types: Other

Identifiers

NCT03055663

1611-069-808

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

Virtual reality sedation

Experimental group

Description:

Patients watches virtual reality sedation program that shows underwater world with comfortable music and narrations during surgery.

Treatment:

Other: Sedation by watching virtual reality sedative program

Sedation with intravenous sedatives

Active Comparator group

Description:

Patients receives intravenous sedative of midazolam (initial bolus 1-2 mg with maintenance dose of 1 mg every 10 - 30 min).

Treatment:

Procedure: Sedation by using intravenous sedative

Drug: Midazolam