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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1% lidocaine | Experimental | epidural anesthesia with 1% lidocaine 10ml before propofol TCI |
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| 2% lidocaine | Experimental | epidural anesthesia with 2% lidocaine 5ml before propofol TCI |
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| 0.9% normal saline | Placebo Comparator | epidural anesthesia with 0.9% normal saline 5ml before propofol TCI |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1% lidocaine | Drug | epidural anesthesia with 1% lidocaine 10ml before propofol TCI |
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| Measure | Description | Time Frame |
|---|---|---|
| The Effect-site Concentration of Propofol | The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia. | The participants will be followed for the duration of anesthesia induction, an expected average of half an hour |
| Measure | Description | Time Frame |
|---|---|---|
| The Bispectral Index | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jun Wang, professor | Dept. of Anesthesiology, First Affiliated Hospital of China Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jun Wang | Shenyang | Liaoning | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1% Lidocaine | epidural anesthesia with 1% lidocaine 10ml before propofol TCI |
| FG001 | 2% Lidocaine | epidural anesthesia with 2% lidocaine 5ml before propofol TCI |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 2% lidocaine | Drug | epidural anesthesia with 2% lidocaine 5ml before propofol TCI |
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| 0.9% normal saline | Drug | epidural anesthesia with 0.9% normal saline 5ml before propofol TCI |
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| The participants will be followed for the duration of anesthesia induction, an expected average of half an hour |
| The Mean Blood Pressure | 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). | The participants will be followed for the duration of anesthesia induction, an expected average of half an hour |
| The Heart Rate | 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). | The participants will be followed for the duration of anesthesia induction, an expected average of half an hour |
| The Block Level of 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). | 20 mins after epidural anesthesia |
| FG002 | 0.9% Normal Saline | epidural anesthesia with 0.9% normal saline 5ml before propofol TCI |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1% Lidocaine | epidural anesthesia with 1% lidocaine 10ml before propofol TCI |
| BG001 | 2% Lidocaine | epidural anesthesia with 2% lidocaine 5ml before propofol TCI |
| BG002 | 0.9% Normal Saline | epidural anesthesia with 0.9% normal saline 5ml before propofol TCI |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | The Effect-site Concentration of Propofol | The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia. | Posted | Mean | Standard Deviation | µg/ml | The participants will be followed for the duration of anesthesia induction, an expected average of half an hour |
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| Secondary | The Bispectral Index | 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). | Posted | Mean | Standard Deviation | units on a scale | The participants will be followed for the duration of anesthesia induction, an expected average of half an hour |
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| Secondary | The Mean Blood Pressure | 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). | Posted | Mean | Standard Deviation | mmHg | The participants will be followed for the duration of anesthesia induction, an expected average of half an hour |
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| Secondary | The Heart Rate | 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). | Posted | Mean | Standard Deviation | beats per minute | The participants will be followed for the duration of anesthesia induction, an expected average of half an hour |
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| Secondary | The Block Level of 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). | Posted | Mean | Standard Deviation | units on a scale | 20 mins after epidural anesthesia |
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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 | Group A | epidural anesthesia with 1% lidocaine 10ml before propofol TCI | 0 | 15 | 0 | 15 | ||
| EG001 | Group B | epidural anesthesia with 2% lidocaine 5ml before propofol TCI | 0 | 15 | 0 | 15 | ||
| EG002 | Group C | epidural anesthesia with 0.9% normal saline 5ml before propofol TCI | 0 | 15 | 0 | 15 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jun Wang | First Hospital of CMU | 8602483283100 | wjun2000@hotmail.com |
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Male |
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