Sedation Using Virtual Reality During Surgery Under Spinal Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-20

Study Completion Date

2017-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Virtual Reality (VR) Could Be a Good Alternative to Relaxing or Pain-relieving Medication

NCT06649383

Virtual Reality Distraction Elderly (people Aged 65 or More)

RECRUITING PHASE4

Impact of Virtual Reality Hypno-sedation on Functional Recovery and Anxiety in Foot Surgery With Regional Anesthesia

NCT05558449

Foot Deformities Regional Anesthesia Morbidity Valgus; Hallux +1 more

COMPLETED PHASE4

Effect of a Virtual Reality Program on Patient Comfort in the Surgical Intensive Care Unit

NCT06830369

Immersive Virtual Reality Discomfort IPREA +2 more

RECRUITING NA

Virtual Reality to Reduce Intra-procedural Anxiety and Sedation Needs During Procedures

NCT04279665

Arrhythmia

WITHDRAWN NA

Virtual Reality Hypnosis in Total Knee Arthroplasty Under Spinal Anesthesia

NCT05707234

Arthroplasty Complications Knee Osteoarthritis Anesthesia Complication +2 more

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Sedation Spinal Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open-labelled

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Virtual reality sedation

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

Group Type EXPERIMENTAL

Sedation by watching virtual reality sedative program

Intervention Type OTHER

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

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).

Group Type ACTIVE_COMPARATOR

Sedation by using intravenous sedative

Intervention Type PROCEDURE

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

Midazolam

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sedation by watching virtual reality sedative program

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

Intervention Type OTHER

Sedation by using intravenous sedative

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

Intervention Type PROCEDURE

Midazolam

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No