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Sedation Using Virtual Reality During Surgery Under Spinal Anesthesia

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ClinicalTrials.gov Identifier: NCT03055663
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Won Ho Kim, MD, 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.


Condition or disease Intervention/treatment Phase
Sedation Spinal Anesthesia Other: Sedation by watching virtual reality sedative program Procedure: Sedation by using intravenous sedative Drug: Midazolam Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized controlled trial
Masking: None (Open Label)
Masking Description: Open-labelled
Primary Purpose: Treatment
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
Actual Study Start Date : February 20, 2017
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Midazolam

Arm Intervention/treatment
Experimental: Virtual reality sedation
Patients watches virtual reality sedation program that shows underwater world with comfortable music and narrations during surgery.
Other: Sedation by watching virtual reality sedative program
Patients watch three-dimensional virtual reality program with headset and headphone during surgery.

Active Comparator: 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).
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)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Satisfaction score of surgeon [ Time Frame: 5 minutes after the end of the main surgical procedure ]
    Surgeon's satisfaction score measured by 5-point Likert-like verbal rating scale

  2. Satisfaction score of anesthesiologist [ Time Frame: 5 minutes after the end of the surgery ]
    Anesthesiologist's satisfaction score measured by 5-point Likert-like verbal rating scale

  3. incidence of adequate sedation [ Time Frame: 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

  4. incidence of desaturation [ Time Frame: 5 min after the end of surgery ]
    incidence of desaturation (pulse oximetry <90% for more than 5 sec) during the surgery

  5. incidence of apnea [ Time Frame: 5 min after the end of surgery ]
    incidence of apnea (no detectable end-tidal carbon dioxide for more than 5 sec) during the surgery

  6. incidence of hypotension [ Time Frame: 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

  7. incidence of bradycardia [ Time Frame: 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

  8. incidence of rescue medication for sedation [ Time Frame: 5 min after the end of surgery ]
    incidence of rescue medication for sedation administered during the surgery

  9. incidence of assisted mask ventilation [ Time Frame: 5 min after the end of surgery ]
    incidence of assisted mask ventilation due to prolonged apnea during the surgery

  10. incidence of nausea [ Time Frame: 5 min after the end of surgery ]
    incidence of nausea of numerical rating scale of more than 5 during the surgery

  11. incidence of vomiting [ Time Frame: 5 min after the end of surgery ]
    incidence of vomiting during the surgery

  12. time to recovery at post-anesthesia care unit [ Time Frame: 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



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055663


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital

Responsible Party: Won Ho Kim, MD, Clinical Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03055663     History of Changes
Other Study ID Numbers: 1611-069-808
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Midazolam
Hypnotics and Sedatives
Adjuvants, Anesthesia
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action