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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

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.

Condition or disease Intervention/treatment Phase
Target Controlled Infusion (TCI) Thoracic Epidural Anesthesia Block Level Gastrointestinal Surgery Drug: 1% lidocaine Drug: 2% lidocaine Drug: 0.9% normal saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Thoracic Epidural Anesthesia With Different Block Level on Propofol Concentration During General Anesthesia Induction
Study Start Date : April 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: C




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135016


Locations
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China, Liaoning
Jun Wang
Shenyang, Liaoning, China
Sponsors and Collaborators
First Hospital of China Medical University
Investigators
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Study Director: Jun Wang, professor Dept. of Anesthesiology, First Affiliated Hospital of China Medical University
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Responsible Party: Jun Wang, professor, First Hospital of China Medical University
ClinicalTrials.gov Identifier: NCT02135016    
Other Study ID Numbers: 20140415
First Posted: May 9, 2014    Key Record Dates
Results First Posted: August 29, 2014
Last Update Posted: August 29, 2014
Last Verified: August 2014
Keywords provided by Jun Wang, First Hospital of China Medical University:
effect-site concentration
propofol
thoracic epidural anesthesia
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action