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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal saline | Placebo Comparator | General anesthesia combined with thoracic epidural 0.9% normal saline 8ml |
|
| Lidocaine | Experimental | General anesthesia combined with thoracic epidural 1% lidocaine 8ml |
|
| Bupivacaine | Experimental | General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml |
|
| Ropivacaine | Experimental | General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | General anesthesia combined with thoracic epidural 1% lidocaine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Arterial Pressure | The mean arterial pressure of each patient was recorded at five different time points | Before starting anesthesia to finishing endotracheal intubation |
| Heart Rate | The heart rate of each patient was recorded at five different time points |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jun Wang | Dept. of Anesthesiology, First Hospital of China Medical University | Study Chair |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Saline | General anesthesia combined with thoracic epidural 0.9% normal saline |
| FG001 | Lidocaine | General anesthesia combined with thoracic epidural 1% lidocaine |
| FG002 | Bupivacaine | General anesthesia combined with thoracic epidural 0.25% bupivacaine |
| FG003 | Ropivacaine | General anesthesia combined with thoracic epidural 0.3% ropivacaine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Saline | General anesthesia combined with thoracic epidural 0.9% normal saline |
| BG001 | Lidocaine | General anesthesia combined with thoracic epidural 1% lidocaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Propofol Effect-site Concentration | The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia. | Posted | Mean | Standard Deviation | ug/ml | Before starting anesthesia to finishing endotracheal intubation |
|
Before starting anesthesia to finishing endotracheal intubation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Saline | General anesthesia combined with thoracic epidural 0.9% normal saline 8ml |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jun Wang | First Hospital of China Medical University | 8602483283100 | wjun2000@hotmail.com |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D002045 | Bupivacaine |
| D000077212 | Ropivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Bupivacaine |
| Drug |
General anesthesia combined with thoracic epidural 0.25% bupivacaine |
|
| Ropivacaine | Drug | General anesthesia combined with thoracic epidural 0.3% ropivacaine |
|
| Normal Saline | Drug | General anesthesia combined with thoracic epidural 0.9% normal saline |
|
| Before starting anesthesia to finishing endotracheal intubation |
| 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 |
| BG002 | Bupivacaine | General anesthesia combined with thoracic epidural 0.25% bupivacaine |
| BG003 | Ropivacaine | General anesthesia combined with thoracic epidural 0.3% ropivacaine |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml |
| OG003 | Ropivacaine | General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml |
|
|
| Secondary | Mean Arterial Pressure | The mean arterial pressure of each patient was recorded at five different time points | Posted | Mean | Standard Deviation | mmHg | Before starting anesthesia to finishing endotracheal intubation |
|
|
|
| Secondary | Heart Rate | The heart rate of each patient was recorded at five different time points | Posted | Mean | Standard Deviation | beats per minute | Before starting anesthesia to finishing endotracheal intubation |
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | Before starting anesthesia to finishing endotracheal intubation |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Lidocaine | General anesthesia combined with thoracic epidural 1% lidocaine 8ml | 0 | 20 | 0 | 20 |
| EG002 | Bupivacaine | General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml | 0 | 20 | 0 | 20 |
| EG003 | Ropivacaine | General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml | 0 | 20 | 0 | 20 |
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| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| 20minites after epidural injection |
|
| Loss of consciousness |
|
| Before endotracheal intubation |
|
| After endotracheal intubation |
|
| 20 minites after epidural injection |
|
| Loss of consciousness |
|
| Before endotracheal intubation |
|
| After endotracheal intubation |
|
| 20 minutes after epidural injection |
|