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CompletedNCT02135016Updated Aug 29, 2014Results posted

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

A Phase 4 interventional study of 1% lidocaine and 2% lidocaine in Target Controlled Infusion (TCI), Thoracic Epidural Anesthesia and Block Level, sponsored by First Hospital of China Medical University. Completed at 1 site in China. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2014-08-29.

Sponsored by First Hospital of China Medical University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

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

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Keywords

  • effect-site concentration
  • propofol
  • thoracic epidural anesthesia
03

In context

Aortic Dissection

386 studies on the registry are indexed under Aortic Dissection; 117 are open to participants now.

This study's enrollment of 45 is below the median of 84 across 198 interventional studies indexed under Aortic Dissection.

Browse Aortic Dissection studies →

Lead sponsor

First Hospital of China Medical University is the lead sponsor of 59 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • patients with cardiovascular or neurological disease, drug or alcohol abuse and absolute contraindications for neuraxial blockade.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    1% lidocaine

    epidural anesthesia with 1% lidocaine 10ml before propofol TCI

    Drug: 1% lidocaine

  • Experimental
    2% lidocaine

    epidural anesthesia with 2% lidocaine 5ml before propofol TCI

    Drug: 2% lidocaine

  • Placebo comparator
    0.9% normal saline

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

    Drug: 0.9% normal saline

Interventions

  • Drug1% lidocaine

    epidural anesthesia with 1% lidocaine 10ml before propofol TCI

    Also known as: A

  • Drug2% lidocaine

    epidural anesthesia with 2% lidocaine 5ml before propofol TCI

    Also known as: B

  • Drug0.9% normal saline

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

    Also known as: C

06

What researchers measure

Primary outcomes

  1. The Effect-site Concentration of Propofol

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

    Time frame: The participants will be followed for the duration of anesthesia induction, an expected average of half an hour

Secondary outcomes

  1. The Bispectral Index

    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).

    Time frame: The participants will be followed for the duration of anesthesia induction, an expected average of half an hour

  2. The Mean Blood Pressure

    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).

    Time frame: The participants will be followed for the duration of anesthesia induction, an expected average of half an hour

  3. The Heart Rate

    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).

    Time frame: The participants will be followed for the duration of anesthesia induction, an expected average of half an hour

  4. The Block Level of 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).

    Time frame: 20 mins after epidural anesthesia

07

Results

Posted Aug 29, 2014

Participant flow

Participant flow — Overall Study
Milestone1% Lidocaine2% Lidocaine0.9% Normal Saline
Started151515
Completed151515
Not completed000

Outcome measures

PrimaryThe Effect-site Concentration of Propofol

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

Time frame:
The participants will be followed for the duration of anesthesia induction, an expected average of half an hour
Reported as:
Mean · µg/ml
The Effect-site Concentration of Propofol
µg/ml1% Lidocaine2% Lidocaine0.9% Normal Saline
The Effect-site Concentration of Propofol1.51 ± 0.441.99 ± 0.372.68 ± 0.68
SecondaryThe Bispectral Index

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).

Time frame:
The participants will be followed for the duration of anesthesia induction, an expected average of half an hour
Reported as:
Mean · units on a scale
The Bispectral Index
units on a scale1% Lidocaine2% Lidocaine0.9% Normal Saline
Baseline95.4 ± 1.495.4 ± 1.495.7 ± 1.3
10mins after epidural aneasthesia85.3 ± 0.785.1 ± 1.394.5 ± 0.9
20mins after epidural aneasthesia84.6 ± 0.983.8 ± 0.894.9 ± 1.8
Loss of consciousness65.7 ± 0.865.3 ± 2.566.1 ± 2.6
SecondaryThe Mean Blood Pressure

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).

Time frame:
The participants will be followed for the duration of anesthesia induction, an expected average of half an hour
Reported as:
Mean · mmHg
The Mean Blood Pressure
mmHg1% Lidocaine2% Lidocaine0.9% Normal Saline
Baseline95.4 ± 2.595.1 ± 2.195.9 ± 2.3
10mins after epidural aneasthesia85.9 ± 3.683.7 ± 2.695.5 ± 2.7
20mins after epidural aneasthesia79.3 ± 2.580.5 ± 3.096.1 ± 2.2
Loss of consciousness74.0 ± 1.474.5 ± 1.082.7 ± 1.3
SecondaryThe Heart Rate

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).

Time frame:
The participants will be followed for the duration of anesthesia induction, an expected average of half an hour
Reported as:
Mean · beats per minute
The Heart Rate
beats per minute1% Lidocaine2% Lidocaine0.9% Normal Saline
Baseline71.4 ± 4.772.8 ± 3.371.3 ± 3.5
10mins after epidural aneasthesia69.8 ± 4.469.2 ± 3.771.3 ± 3.5
20mins after epidural aneasthesia68.5 ± 3.467.2 ± 3.470.3 ± 3.3
Loss of consciousness63.2 ± 1.862.3 ± 1.963.2 ± 1.8
SecondaryThe Block Level of 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).

Time frame:
20 mins after epidural anesthesia
Reported as:
Mean · units on a scale
The Block Level of Epidural Anesthesia
units on a scale1% Lidocaine2% Lidocaine0.9% Normal Saline
The Block Level of Epidural Anesthesia6.5 ± 1.04.2 ± 0.90 ± 0

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group A—0/15 (0%)0/15 (0%)
Group B—0/15 (0%)0/15 (0%)
Group C—0/15 (0%)0/15 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)1% Lidocaine2% Lidocaine0.9% Normal SalineTotal
Mean58 ± 657 ± 7.056 ± 456 ± 6
Sex: Female, Male
Sex: Female, Male(Participants)1% Lidocaine2% Lidocaine0.9% Normal SalineTotal
Female76720
Male89825
08

Study locations

1 site
  • Jun Wang
    Shenyang, Liaoning, China
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02135016
Lead sponsor
First Hospital of China Medical University
Responsible party
Jun Wang (professor, First Hospital of China Medical University) — Principal investigator
First posted
May 9, 2014
Start date
Apr 2014
Primary completion
Jul 2014
Completion
Jul 2014
Results posted
Aug 29, 2014
Last update
Aug 29, 2014

Study contacts

Jun Wang, professor
study director · Dept. of Anesthesiology, First Affiliated Hospital of China Medical University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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