Effects of Epidural Local Anesthetics on Propofol Induction

Phase 4

Completed

• Conditions: General Anesthesia; Propofol Target-controlled Infusion; Thoracic Epidural Anesthesia
• Interventions: Drug: Normal Saline; Drug: Bupivacaine; Drug: Lidocaine; Drug: Ropivacaine

• Registration Number: NCT02000973
• Lead Sponsor: First Hospital of China Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-22
• Study First Submitted QC: 2013-12-03
• Study First Posted: 2013-12-04
• Primary Completion: 2014-01
• Study Completion: 2014-03
• Results First Submitted: 2014-03-06
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-20
• Last Update Submitted: 2014-04-20
• Results First Posted: 2014-05-16
• Last Update Posted: 2014-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	Normal Saline	General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
Bupivacaine	Bupivacaine	General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
Lidocaine	Lidocaine	General anesthesia combined with thoracic epidural 1% lidocaine 8ml
Ropivacaine	Ropivacaine	General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml

Primary Outcome Measures

Name	Time	Method
Propofol Effect-site Concentration	Before starting anesthesia to finishing endotracheal intubation	The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia.

Secondary Outcome Measures

Name	Time	Method
Heart Rate	Before starting anesthesia to finishing endotracheal intubation	The heart rate of each patient was recorded at five different time points
Bispectral Index Score	Before starting anesthesia to finishing endotracheal intubation	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).
Mean Arterial Pressure	Before starting anesthesia to finishing endotracheal intubation	The mean arterial pressure of each patient was recorded at five different time points