Sedation, Spinal Anesthesia
Conditions
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.
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.
Interventions
OTHERSedation by watching virtual reality sedative program
Patients watch three-dimensional virtual reality program with headset and headphone during surgery.
PROCEDURESedation by using intravenous sedative
Patients receive intravenous sedative (midazolam 1-2 mg bolus with 1 mg maintenance dose every 10- 30 minutes)
DRUGMidazolam
Patients receive intravenous sedative (midazolam 1-2 mg bolus with 1 mg maintenance dose every 10- 30 minutes)
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open-labelled
Intervention model description
Prospective, randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction score of patient | 20 minutes after the arrival at the postanesthesia care unit | Patient's satisfaction score measured by 5-point Likert-like verbal rating scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction score of anesthesiologist | 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 | 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 | 5 min after the end of surgery | incidence of desaturation (pulse oximetry \<90% for more than 5 sec) during the surgery |
| incidence of apnea | 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 | 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 |
| Satisfaction score of surgeon | 5 minutes after the end of the main surgical procedure | Surgeon's satisfaction score measured by 5-point Likert-like verbal rating scale |
| incidence of rescue medication for sedation | 5 min after the end of surgery | incidence of rescue medication for sedation administered during the surgery |
| incidence of assisted mask ventilation | 5 min after the end of surgery | incidence of assisted mask ventilation due to prolonged apnea during the surgery |
| incidence of nausea | 5 min after the end of surgery | incidence of nausea of numerical rating scale of more than 5 during the surgery |
| incidence of vomiting | 5 min after the end of surgery | incidence of vomiting during the surgery |
| time to recovery at post-anesthesia care unit | 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 |
| incidence of bradycardia | 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 |
Countries
South Korea
Outcome results
None listed