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

NCT ID: NCT02135016

Last Updated: 2014-08-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-07-31

Brief Summary

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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

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Conditions

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

Keywords

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effect-site concentration propofol thoracic epidural anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1% lidocaine

epidural anesthesia with 1% lidocaine 10ml before propofol TCI

Group Type EXPERIMENTAL

1% lidocaine

Intervention Type DRUG

epidural anesthesia with 1% lidocaine 10ml before propofol TCI

2% lidocaine

epidural anesthesia with 2% lidocaine 5ml before propofol TCI

Group Type EXPERIMENTAL

2% lidocaine

Intervention Type DRUG

epidural anesthesia with 2% lidocaine 5ml before propofol TCI

0.9% normal saline

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

Group Type PLACEBO_COMPARATOR

0.9% normal saline

Intervention Type DRUG

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

Interventions

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1% lidocaine

epidural anesthesia with 1% lidocaine 10ml before propofol TCI

Intervention Type DRUG

2% lidocaine

epidural anesthesia with 2% lidocaine 5ml before propofol TCI

Intervention Type DRUG

0.9% normal saline

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

Intervention Type DRUG

Other Intervention Names

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A B C

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Hospital of China Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jun Wang

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jun Wang, professor

Role: STUDY_DIRECTOR

Dept. of Anesthesiology, First Affiliated Hospital of China Medical University

Locations

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Jun Wang

Shenyang, Liaoning, China

Site Status

Countries

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China

Other Identifiers

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20140415

Identifier Type: -

Identifier Source: org_study_id