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

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ClinicalTrials.gov Identifier: NCT02135016
Recruitment Status : Completed
First Posted : May 9, 2014
Results First Posted : August 29, 2014
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
Jun Wang, First Hospital of China Medical University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Target Controlled Infusion (TCI)
Thoracic Epidural Anesthesia
Block Level
Gastrointestinal Surgery
Interventions Drug: 1% lidocaine
Drug: 2% lidocaine
Drug: 0.9% normal saline
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1% Lidocaine 2% Lidocaine 0.9% Normal Saline
Hide Arm/Group Description epidural anesthesia with 1% lidocaine 10ml before propofol TCI epidural anesthesia with 2% lidocaine 5ml before propofol TCI epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
Period Title: Overall Study
Started 15 15 15
Completed 15 15 15
Not Completed 0 0 0
Arm/Group Title 1% Lidocaine 2% Lidocaine 0.9% Normal Saline Total
Hide Arm/Group Description epidural anesthesia with 1% lidocaine 10ml before propofol TCI epidural anesthesia with 2% lidocaine 5ml before propofol TCI epidural anesthesia with 0.9% normal saline 5ml before propofol TCI Total of all reporting groups
Overall Number of Baseline Participants 15 15 15 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 15 participants 45 participants
58  (6) 57  (7.0) 56  (4) 56  (6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 45 participants
Female
7
  46.7%
6
  40.0%
7
  46.7%
20
  44.4%
Male
8
  53.3%
9
  60.0%
8
  53.3%
25
  55.6%
1.Primary Outcome
Title The Effect-site Concentration of Propofol
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1% Lidocaine 2% Lidocaine 0.9% Normal Saline
Hide Arm/Group Description:
epidural anesthesia with 1% lidocaine 10ml before propofol TCI
epidural anesthesia with 2% lidocaine 5ml before propofol TCI
epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
Overall Number of Participants Analyzed 15 15 15
Mean (Standard Deviation)
Unit of Measure: µg/ml
1.51  (0.44) 1.99  (0.37) 2.68  (0.68)
2.Secondary Outcome
Title The Bispectral Index
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1% Lidocaine 2% Lidocaine 0.9% Normal Saline
Hide Arm/Group Description:
epidural anesthesia with 1% lidocaine 10ml before propofol TCI
epidural anesthesia with 2% lidocaine 5ml before propofol TCI
epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
Overall Number of Participants Analyzed 15 15 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 95.4  (1.4) 95.4  (1.4) 95.7  (1.3)
10mins after epidural aneasthesia 85.3  (0.7) 85.1  (1.3) 94.5  (0.9)
20mins after epidural aneasthesia 84.6  (0.9) 83.8  (0.8) 94.9  (1.8)
Loss of consciousness 65.7  (0.8) 65.3  (2.5) 66.1  (2.6)
3.Secondary Outcome
Title The Mean Blood Pressure
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1% Lidocaine 2% Lidocaine 0.9% Normal Saline
Hide Arm/Group Description:
epidural anesthesia with 1% lidocaine 10ml before propofol TCI
epidural anesthesia with 2% lidocaine 5ml before propofol TCI
epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
Overall Number of Participants Analyzed 15 15 15
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline 95.4  (2.5) 95.1  (2.1) 95.9  (2.3)
10mins after epidural aneasthesia 85.9  (3.6) 83.7  (2.6) 95.5  (2.7)
20mins after epidural aneasthesia 79.3  (2.5) 80.5  (3.0) 96.1  (2.2)
Loss of consciousness 74.0  (1.4) 74.5  (1.0) 82.7  (1.3)
4.Secondary Outcome
Title The Heart Rate
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1% Lidocaine 2% Lidocaine 0.9% Normal Saline
Hide Arm/Group Description:
epidural anesthesia with 1% lidocaine 10ml before propofol TCI
epidural anesthesia with 2% lidocaine 5ml before propofol TCI
epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
Overall Number of Participants Analyzed 15 15 15
Mean (Standard Deviation)
Unit of Measure: beats per minute
Baseline 71.4  (4.7) 72.8  (3.3) 71.3  (3.5)
10mins after epidural aneasthesia 69.8  (4.4) 69.2  (3.7) 71.3  (3.5)
20mins after epidural aneasthesia 68.5  (3.4) 67.2  (3.4) 70.3  (3.3)
Loss of consciousness 63.2  (1.8) 62.3  (1.9) 63.2  (1.8)
5.Secondary Outcome
Title The Block Level of Epidural Anesthesia
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1% Lidocaine 2% Lidocaine 0.9% Normal Saline
Hide Arm/Group Description:
epidural anesthesia with 1% lidocaine 10ml before propofol TCI
epidural anesthesia with 2% lidocaine 5ml before propofol TCI
epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
Overall Number of Participants Analyzed 15 15 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.5  (1.0) 4.2  (0.9) 0  (0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description epidural anesthesia with 1% lidocaine 10ml before propofol TCI epidural anesthesia with 2% lidocaine 5ml before propofol TCI epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
All-Cause Mortality
Group A Group B Group C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Group A Group B Group C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A Group B Group C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jun Wang
Organization: First Hospital of CMU
Phone: 8602483283100
EMail: wjun2000@hotmail.com
Layout table for additonal information
Responsible Party: Jun Wang, First Hospital of China Medical University
ClinicalTrials.gov Identifier: NCT02135016    
Other Study ID Numbers: 20140415
First Submitted: April 30, 2014
First Posted: May 9, 2014
Results First Submitted: August 8, 2014
Results First Posted: August 29, 2014
Last Update Posted: August 29, 2014