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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

February 14, 2017
February 16, 2017
April 3, 2018
February 20, 2017
October 31, 2017   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT03055663 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • incidence of vomiting [ Time Frame: 5 min after the end of surgery ]
    incidence of vomiting during the surgery
  • 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
  • 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
  • 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
  • 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
Not Provided
Not Provided
 
Sedation Using Virtual Reality During Surgery Under Spinal Anesthesia
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective, randomized controlled trial
Masking: None (Open Label)
Masking Description:
Open-labelled
Primary Purpose: Treatment
  • Sedation
  • Spinal Anesthesia
  • 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)
  • Experimental: Virtual reality sedation
    Patients watches virtual reality sedation program that shows underwater world with comfortable music and narrations during surgery.
    Intervention: Other: Sedation by watching virtual reality sedative program
  • 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).
    Interventions:
    • Procedure: Sedation by using intravenous sedative
    • Drug: Midazolam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
Same as current
October 31, 2017
October 31, 2017   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT03055663
1611-069-808
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Won Ho Kim, MD, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Not Provided
Seoul National University Hospital
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP