Surgery Related to Lower Extremity Under Spinal Anesthesia
Conditions
Brief summary
Sedation during spinal anesthesia is very useful for patients' comfort. However, intermittent bolus of sedative frequently results in inappropriate sedation which comes with various side effects such as patients' discomfort and apnea. Therefore, it would be reasonable to use target-controlled infusion(TCI) to provide proper sedation without serious side effects. In this study, the investigators try to find the appropriate propofol target concentration with TCI device and build a pharmacodynamic non-linear mixed effect model between propofol target concentration and side effects.
Interventions
None listed
Sponsors
Yonsei University
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients who have lower extremity surgery under spinal anesthesia and who want to be sedated
Exclusion criteria
* patients who have deafness, neurologic deficit, Glasgow coma scale less than 15, history of drug allergy and who are on central nervous system-related drugs,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sedation score | every 5 minutes when the dose is adjusted up to 1 hour | Sedation score will be assessed with 'Modified Observer's assessment of alertness/sedation (OAA/S) score'. It has 5 scales from 1 to 5 as followed. 1. responds readily to name spoken in normal tone 2. lethargic response to name spoken in normal tone 3. responds only after name is spoken loudly and/or repeatedly 4. responds only after mild prodding or shaking 5. does not respond to mild prodding or shaking After induction of spinal anesthesia, patient will be sedated with propofol via TCI device. The infusion dose will be adjusted every 5 minutes until the OAA/S score reaches 4. The patient's OAA/S score will be assessed overtime the infusion dose is adjusted during sedation. At the same time, airway obstruction score will be assessed and if the score reaches 4, the dose will be reduced. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| airway obstruction score | every 5 minutes when the dose is adjusted up to 1 hour | Airway obstruction score will be assessed as followed. 1. normal breathing 2. deep breathing 3. snoring 4. severe airway obstruction After induction of spinal anesthesia, patient will be sedated with propofol via TCI device. The infusion dose will be adjusted every 5 minutes until the OAA/S score reaches 4. The patient's OAA/S score will be assessed overtime the infusion dose is adjusted during sedation. At the same time, airway obstruction score will be assessed and if the score reaches 4, the dose will be reduced. |
Countries
South Korea
Outcome results
None listed