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NCT Number: NCT02135016

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

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Key information

Conditions

Target Controlled Infusion (TCI) Block Level Gastrointestinal Surgery Thoracic Epidural Anesthesia

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jun Wang

Shenyang, Liaoning, China

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

1% Lidocaine

Drug

epidural anesthesia with 1% lidocaine 10ml before propofol TCI

Other names: A

2% lidocaine

Drug

epidural anesthesia with 2% lidocaine 5ml before propofol TCI

Other names: B

0.9% normal saline

Drug

epidural anesthesia with 0.9% normal saline 5ml before propofol TCI

Other names: C

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

First Hospital of China Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 9, 2014
Registry last updated
Aug 29, 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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