Population Pharmacodynamic Modeling of the Sedative and Side Effects of Propofol

Yonsei University30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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,

Locations (1)

Gangnam Severance Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

sedation score

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.

Time frame: every 5 minutes when the dose is adjusted up to 1 hour

Secondary Outcomes

airway obstruction score

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.

Time frame: every 5 minutes when the dose is adjusted up to 1 hour