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Completed

NCT Number: NCT02000973

Effects of Epidural Local Anesthetics on Propofol Induction

The investigators designed a prospective, randomized, placebo-controlled study to determine whether thoracic epidural anesthesia(TEA) with different local anesthetics has different influences on the propofol dose during induction.

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Key information

Conditions

General Anesthesia Propofol Target-controlled Infusion Thoracic Epidural Anesthesia

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Surgery for thoracotomies, BMI: 18-25 Kg/m2, American Society of Anesthesiologists(ASA) classification I or II.

Exclusion criteria

liver or kidney disease, alcohol dependence, take sedative recently, contraindications for epidural anesthesia.

Treatment and study plan

Lidocaine

Drug

General anesthesia combined with thoracic epidural 1% lidocaine

Bupivacaine

Drug

General anesthesia combined with thoracic epidural 0.25% bupivacaine

Ropivacaine

Drug

General anesthesia combined with thoracic epidural 0.3% ropivacaine

normal saline

Drug

General anesthesia combined with thoracic epidural 0.9% normal saline

Primary outcomes

  1. Propofol Effect-site Concentration

    Time frame: Before starting anesthesia to finishing endotracheal intubation

    The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia.

Secondary outcomes

  1. Mean Arterial Pressure

    Time frame: Before starting anesthesia to finishing endotracheal intubation

    The mean arterial pressure of each patient was recorded at five different time points

  2. Heart Rate

    Time frame: Before starting anesthesia to finishing endotracheal intubation

    The heart rate of each patient was recorded at five different time points

  3. Bispectral Index Score

    Time frame: Before starting anesthesia to finishing endotracheal intubation

    The bispectral index(BIS) score of each patient was recorded at two different time points. BIS values varies from 0 to 100(0, no cerebral activity; 40 to 60, general anesthesia; 60 to 85, sedated; 85 to 100, awake).

Sponsors and collaborators

Lead sponsor

First Hospital of China Medical University

Other

Registry information

Official study title

Effects of Thoracic Epidural Anesthesia With Different Local Anesthetics on Propofol Induction

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 4, 2013
Registry last updated
May 16, 2014

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.

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