SedationNCT03055663
Sedation Using Virtual Reality During Surgery Under Spinal Anesthesia
A study testing Sedation by watching virtual reality sedative program, Sedation by using intravenous sedative and Midazolam in people with Sedation and Spinal Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sedation, Spinal Anesthesia
- What is being tested?
- Sedation by watching virtual reality sedative program, Sedation by using intravenous sedative and Midazolam
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Feb 2017to 31 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Sedation, Spinal Anesthesia
- Being tested
- Sedation by watching virtual reality sedative program, Sedation by using intravenous sedative, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedation by watching virtual reality sedative programOther
Patients watch three-dimensional virtual reality program with headset and headphone during surgery.
Sedation by using intravenous sedativeProcedure or surgery
Patients receive intravenous sedative (midazolam 1-2 mg bolus with 1 mg maintenance dose every 10- 30 minutes)
MidazolamDrug
Patients receive intravenous sedative (midazolam 1-2 mg bolus with 1 mg maintenance dose every 10- 30 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality sedation | Experimental | Patients watches virtual reality sedation program that shows underwater world with comfortable music and narrations during surgery. Receives: Other: Sedation by watching virtual reality sedative program |
| Sedation with intravenous sedatives | Active comparator | Patients receives intravenous sedative of midazolam (initial bolus 1-2 mg with maintenance dose of 1 mg every 10 - 30 min). Receives: Procedure: Sedation by using intravenous sedative; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction score of patient
Patient's satisfaction score measured by 5-point Likert-like verbal rating scale
Measured: 20 minutes after the arrival at the postanesthesia care unit
Secondary outcomes (12)
Satisfaction score of surgeon
Surgeon's satisfaction score measured by 5-point Likert-like verbal rating scale
Measured: 5 minutes after the end of the main surgical procedure
Satisfaction score of anesthesiologist
Anesthesiologist's satisfaction score measured by 5-point Likert-like verbal rating scale
Measured: 5 minutes after the end of the surgery
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
Measured: 5 minutes after the end of surgery
incidence of desaturation
incidence of desaturation (pulse oximetry <90% for more than 5 sec) during the surgery
Measured: 5 min after the end of surgery
incidence of apnea
incidence of apnea (no detectable end-tidal carbon dioxide for more than 5 sec) during the surgery
Measured: 5 min after the end of surgery
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
Measured: 5 min after the end of surgery
incidence of bradycardia
incidence of bradycardia (decrease in heart rate of more than 30% of baseline or heart rate fall below 50 beats/min
Measured: 5 min after the end of surgery
incidence of rescue medication for sedation
incidence of rescue medication for sedation administered during the surgery
Measured: 5 min after the end of surgery
incidence of assisted mask ventilation
incidence of assisted mask ventilation due to prolonged apnea during the surgery
Measured: 5 min after the end of surgery
incidence of nausea
incidence of nausea of numerical rating scale of more than 5 during the surgery
Measured: 5 min after the end of surgery
incidence of vomiting
incidence of vomiting during the surgery
Measured: 5 min after the end of surgery
time to recovery at post-anesthesia care unit
time to report the modified Aldrete score of 9 or more at post-anesthesia care unit
Measured: 5 min after the stay in the post-anesthesia care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start20 Feb 2017
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Ho Kim, MD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055663
- Sponsor's protocol ID
- 1611-069-808
- Status last verified
- Apr 2018
- First submitted
- 14 Feb 2017
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03055663
- Acronym / sponsor ID
- 1611-069-808
- Conditions
- Sedation, Spinal Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Virtual reality sedation | Experimental | Other: Sedation by watching virtual reality sedative programPatients watches virtual reality sedation program that shows underwater world with comfortable music and narrations during surgery. |
| Sedation with intravenous sedatives | Active comparator | Procedure: Sedation by using intravenous sedative, Drug: MidazolamPatients receives intravenous sedative of midazolam (initial bolus 1-2 mg with maintenance dose of 1 mg every 10 - 30 min). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sedation by watching virtual reality sedative programPatients watch three-dimensional virtual reality program with headset and headphone during surgery. | Other | Virtual reality sedation |
| Sedation by using intravenous sedativePatients receive intravenous sedative (midazolam 1-2 mg bolus with 1 mg maintenance dose every 10- 30 minutes) | Procedure or surgery | Sedation with intravenous sedatives |
| MidazolamPatients receive intravenous sedative (midazolam 1-2 mg bolus with 1 mg maintenance dose every 10- 30 minutes) | Drug | Sedation with intravenous sedatives |
Primary outcome
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
12 secondary outcomes
Satisfaction score of surgeon
Time frame: 5 minutes after the end of the main surgical procedure
Satisfaction score of anesthesiologist
Time frame: 5 minutes after the end of the surgery
incidence of adequate sedation
Time frame: 5 minutes after the end of surgery
incidence of desaturation
Time frame: 5 min after the end of surgery
incidence of apnea
Time frame: 5 min after the end of surgery
incidence of hypotension
Time frame: 5 min after the end of surgery
incidence of bradycardia
Time frame: 5 min after the end of surgery
incidence of rescue medication for sedation
Time frame: 5 min after the end of surgery
incidence of assisted mask ventilation
Time frame: 5 min after the end of surgery
incidence of nausea
Time frame: 5 min after the end of surgery
incidence of vomiting
Time frame: 5 min after the end of surgery
time to recovery at post-anesthesia care unit
Time frame: 5 min after the stay in the post-anesthesia care unit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Sedation
Not yet recruiting
Testing the Timing and Application of Virtual Reality Distraction During Knee Injections in a VA Pain Clinic
Pain Management, Injection Pain Prevention
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
Recruiting
Conscious Sedation Versus General Anesthesia for Pulsed Field Ablation in Paroxysmal Atrial Fibrillation
Paroxysmal Atrial Fibrillation
RecruitingPhase 3
Ketamine Sedation in the ICU (KANINE) RCT
Mechanical Ventilation, Critically Ill Intensive Care Unit Patients
Not yet recruiting
Dexametedomidine Ketamine Infusion Versus Dexametedomidine Propofol Infusion in Non-compliant Agitated Patients on Continuous Positive Airway Pressure (CPAP) Mask Ventilation in the Intensive Care Unit
CPAP Ventilation, Sedation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedation by watching virtual reality sedative program, Sedation by using intravenous sedative and Midazolam in people with Sedation and Spinal Anesthesia, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction score of patient (time frame: 20 minutes after the arrival at the postanesthesia care unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2018.