Effects of Epidural Local Anesthetics on Propofol Induction

April 20, 2014 updated by: Jun Wang, First Hospital of China Medical University

Effects of Thoracic Epidural Anesthesia With Different 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Normal saline
General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
Drug: Normal Saline
General anesthesia combined with thoracic epidural 0.9% normal saline
Experimental: Lidocaine
General anesthesia combined with thoracic epidural 1% lidocaine 8ml
Drug: Lidocaine
General anesthesia combined with thoracic epidural 1% lidocaine
Experimental: Bupivacaine
General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
Drug: Bupivacaine
General anesthesia combined with thoracic epidural 0.25% bupivacaine
Experimental: Ropivacaine
General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
Drug: Ropivacaine
General anesthesia combined with thoracic epidural 0.3% ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before starting anesthesia to finishing endotracheal intubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before starting anesthesia to finishing endotracheal intubation
Heart Rate
Time Frame: Before starting anesthesia to finishing endotracheal intubation
The heart rate of each patient was recorded at five different time points
Before starting anesthesia to finishing endotracheal intubation
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).
Before starting anesthesia to finishing endotracheal intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Hospital of China Medical University

Investigators

  • Study Chair: Jun Wang, Dept. of Anesthesiology, First Hospital of China Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

November 22, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 4, 2013

Study Record Updates

Last Update Posted (Estimate)

May 16, 2014

Last Update Submitted That Met QC Criteria

April 20, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20131012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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