Population Pharmacodynamic Modeling of the Sedative and Side Effects of Propofol

Population Pharmacodynamic Modeling of the Sedative and Side Effects of Propofol in Patients Undergoing Spinal Anesthesia

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 Overview

• Status: Completed
• Conditions: Surgery Related to Lower Extremity Under Spinal Anesthesia

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients who have lower extremity surgery under spinal anesthesia at Gangnam Severance Hospital

Description

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,

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.; responds readily to name spoken in normal tone; lethargic response to name spoken in normal tone; responds only after name is spoken loudly and/or repeatedly; responds only after mild prodding or shaking; 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.	every 5 minutes when the dose is adjusted up to 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
airway obstruction score	Airway obstruction score will be assessed as followed.; normal breathing; deep breathing; snoring; 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.	every 5 minutes when the dose is adjusted up to 1 hour

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Dong Woo Han, MD, PhD, Yonsei University Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: May 19, 2014
• First Submitted That Met QC Criteria: June 23, 2014
• First Posted (Estimate): June 24, 2014

Study Record Updates

• Last Update Posted (Estimate): July 29, 2015
• Last Update Submitted That Met QC Criteria: July 27, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 3-2011-0247