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Completed

NCT Number: NCT02173340

Population Pharmacodynamic Modeling of the Sedative and Side Effects of Propofol

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.

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Key information

Conditions

Surgery Related to Lower Extremity Under Spinal Anesthesia

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gangnam Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Primary outcomes

  1. sedation score

    Time frame: 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.

    • 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.

Secondary outcomes

  1. airway obstruction score

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

    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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 24, 2014
Registry last updated
Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.