Population Pharmacodynamic Modeling of the Sedative and Side Effects of Propofol

Yonsei University

Status: Completed

Conditions: Surgery Related to Lower Extremity Under Spinal Anesthesia

Study type: Observational

Funder types: Other

Identifiers

NCT02173340

3-2011-0247

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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,