Population Pharmacodynamic Modeling of the Sedative and Side Effects of Propofol

Completed

• Conditions: Surgery Related to Lower Extremity Under Spinal Anesthesia

• Registration Number: NCT02173340
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-19
• Study Start: 2014-06
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-24
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• patients who have lower extremity surgery under spinal anesthesia and who want to be sedated

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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,

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of