The Effect of Thoracic Epidural Anesthesia With Different Block Level on Propofol Induction

August 28, 2014 updated by: Jun Wang, First Hospital of China Medical University

The Effect of Thoracic Epidural Anesthesia With Different Block Level on Propofol Concentration During General Anesthesia Induction

It is a prospective, randomized, placebo-controlled study to investigate the effect of TEA with different block level on propofol concentration during general anesthesia induction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China
        • Jun Wang

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

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) I-II physical status,
  • aged 40-60 yr,
  • BMI 19-25 kg/m2,
  • undergoing elective gastrointestinal surgery

Exclusion Criteria:

  • patients with cardiovascular or neurological disease, drug or alcohol abuse and absolute contraindications for neuraxial blockade.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1% lidocaine
epidural anesthesia with 1% lidocaine 10ml before propofol TCI
Drug: 1% lidocaine
epidural anesthesia with 1% lidocaine 10ml before propofol TCI
Other Names:
  • A
Experimental: 2% lidocaine
epidural anesthesia with 2% lidocaine 5ml before propofol TCI
Drug: 2% lidocaine
epidural anesthesia with 2% lidocaine 5ml before propofol TCI
Other Names:
  • B
Placebo Comparator: 0.9% normal saline
epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
Drug: 0.9% normal saline
epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
Other Names:
  • C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Effect-site Concentration of Propofol
Time Frame: The participants will be followed for the duration of anesthesia induction, an expected average of half an hour
The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia.
The participants will be followed for the duration of anesthesia induction, an expected average of half an hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Bispectral Index
Time Frame: The participants will be followed for the duration of anesthesia induction, an expected average of half an hour
The bispectral index (BIS) of each patient will be recorded at four different time points,as follows, baseline(the awake phase before epidural anesthesia),10 mins after epidural anesthesia, 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia). BIS values varies from 0 to 100(0, no cerebral activity; 40 to 60, general anesthesia; 60 to 85, sedated; 85 to 100, awake).
The participants will be followed for the duration of anesthesia induction, an expected average of half an hour
The Mean Blood Pressure
Time Frame: The participants will be followed for the duration of anesthesia induction, an expected average of half an hour
The mean arterial pressure of each patient will be recorded at four different time points, as follows, baseline(the awake phase before epidural anesthesia), 10 mins after epidural anesthesia, 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia).
The participants will be followed for the duration of anesthesia induction, an expected average of half an hour
The Heart Rate
Time Frame: The participants will be followed for the duration of anesthesia induction, an expected average of half an hour
The heart rate of each patient will be recorded at three different four points, as follows, baseline(the awake phase before epidural anesthesia), 10mins after epidural anesthesia, 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia).
The participants will be followed for the duration of anesthesia induction, an expected average of half an hour
The Block Level of Epidural Anesthesia
Time Frame: 20 mins after epidural anesthesia
The block level 20mins after epidural anesthesia and it is verified by the loss of sensation to alcohol swab before target controlled infusion of propofol.It is the number of block segments.The block level varies from 0 to 10(0, no block level; 1 to 5, narrow block level;6 to 10, wide block level).
20 mins after epidural anesthesia

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 Director: Jun Wang, professor, Dept. of Anesthesiology, First Affiliated 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

April 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

April 30, 2014

First Submitted That Met QC Criteria

May 7, 2014

First Posted (Estimate)

May 9, 2014

Study Record Updates

Last Update Posted (Estimate)

August 29, 2014

Last Update Submitted That Met QC Criteria

August 28, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20140415

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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