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NCT02000973 Clinical Trial

Effects of Epidural Local Anesthetics on Propofol Induction

General Anesthesia Clinical Trial

Official title:
Effects of Thoracic Epidural Anesthesia With Different Local Anesthetics on Propofol Induction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02000973
Other study ID # 20131012
Secondary ID
Status Completed
Phase Phase 4
First received November 22, 2013
Last updated April 20, 2014
Start date November 2013
Est. completion date March 2014

Study information
Verified date April 2014
Source First Hospital of China Medical University
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

The investigators designed a prospective, randomized, placebo-controlled study to determine whether thoracic epidural anesthesia(TEA) with different local anesthetics has different influences on the propofol dose during induction.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date March 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 45 Years to 65 Years
Eligibility Inclusion Criteria:

Surgery for thoracotomies, BMI: 18-25 Kg/m2, American Society of Anesthesiologists(ASA) classification I or II.

Exclusion Criteria:

liver or kidney disease, alcohol dependence, take sedative recently, contraindications for epidural anesthesia.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lidocaine
General anesthesia combined with thoracic epidural 1% lidocaine
• Bupivacaine
General anesthesia combined with thoracic epidural 0.25% bupivacaine
• Ropivacaine
General anesthesia combined with thoracic epidural 0.3% ropivacaine
• Normal Saline
General anesthesia combined with thoracic epidural 0.9% normal saline

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
First Hospital of China Medical University

Outcome
Type Measure Description Time frame Safety issue
Primary Propofol Effect-site Concentration The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia. Before starting anesthesia to finishing endotracheal intubation No
Secondary Mean Arterial Pressure The mean arterial pressure of each patient was recorded at five different time points Before starting anesthesia to finishing endotracheal intubation No
Secondary Heart Rate The heart rate of each patient was recorded at five different time points Before starting anesthesia to finishing endotracheal intubation No
Secondary Bispectral Index Score The bispectral index(BIS) score of each patient was recorded at two different time points. BIS values varies from 0 to 100(0, no cerebral activity; 40 to 60, general anesthesia; 60 to 85, sedated; 85 to 100, awake). Before starting anesthesia to finishing endotracheal intubation No
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