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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

Tracking Information
First Submitted Date  ICMJE April 30, 2014
First Posted Date  ICMJE May 9, 2014
Results First Submitted Date  ICMJE August 8, 2014
Results First Posted Date  ICMJE August 29, 2014
Last Update Posted Date August 29, 2014
Study Start Date  ICMJE April 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2014)
  • 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 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 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 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2014)
  • 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 of each patient will be recorded at three different time points,as follows, baseline(the awake phase before epidural anesthesia), 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia).
  • 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 three different time points, as follows, baseline(the awake phase before epidural anesthesia), 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia).
  • 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 time points, as follows, baseline(the awake phase before epidural anesthesia), 20 mins after epidural anesthesia, loss of consciousness(when the participants are lost eyelash reflex during propofol TCI induction of anesthesia).
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Thoracic Epidural Anesthesia With Different Block Level on Propofol Induction
Official Title  ICMJE The Effect of Thoracic Epidural Anesthesia With Different Block Level on Propofol Concentration During General Anesthesia Induction
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Target Controlled Infusion (TCI)
  • Thoracic Epidural Anesthesia
  • Block Level
  • Gastrointestinal Surgery
Intervention  ICMJE
  • Drug: 1% lidocaine
    epidural anesthesia with 1% lidocaine 10ml before propofol TCI
    Other Name: A
  • Drug: 2% lidocaine
    epidural anesthesia with 2% lidocaine 5ml before propofol TCI
    Other Name: B
  • Drug: 0.9% normal saline
    epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
    Other Name: C
Study Arms  ICMJE
  • Experimental: 1% lidocaine
    epidural anesthesia with 1% lidocaine 10ml before propofol TCI
    Intervention: Drug: 1% lidocaine
  • Experimental: 2% lidocaine
    epidural anesthesia with 2% lidocaine 5ml before propofol TCI
    Intervention: Drug: 2% lidocaine
  • Placebo Comparator: 0.9% normal saline
    epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
    Intervention: Drug: 0.9% normal saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2014)
45
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02135016
Other Study ID Numbers  ICMJE 20140415
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jun Wang, First Hospital of China Medical University
Study Sponsor  ICMJE First Hospital of China Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jun Wang, professor Dept. of Anesthesiology, First Affiliated Hospital of China Medical University
PRS Account First Hospital of China Medical University
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP