General Anesthesia, Propofol Target-controlled Infusion, Thoracic Epidural Anesthesia
Conditions
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.
Interventions
DRUGLidocaine
General anesthesia combined with thoracic epidural 1% lidocaine
DRUGBupivacaine
General anesthesia combined with thoracic epidural 0.25% bupivacaine
DRUGRopivacaine
General anesthesia combined with thoracic epidural 0.3% ropivacaine
DRUGNormal Saline
General anesthesia combined with thoracic epidural 0.9% normal saline
Sponsors
First Hospital of China Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Mean Arterial Pressure | Before starting anesthesia to finishing endotracheal intubation | The mean arterial pressure of each patient was recorded at five different time points |
| 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). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Normal Saline General anesthesia combined with thoracic epidural 0.9% normal saline | 20 |
| Lidocaine General anesthesia combined with thoracic epidural 1% lidocaine | 20 |
| Bupivacaine General anesthesia combined with thoracic epidural 0.25% bupivacaine | 20 |
| Ropivacaine General anesthesia combined with thoracic epidural 0.3% ropivacaine | 20 |
| Total | 80 |
Baseline characteristics
| Characteristic | Normal Saline | Lidocaine | Bupivacaine | Ropivacaine | Total |
|---|---|---|---|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 6 | 57 years STANDARD_DEVIATION 6 | 57 years STANDARD_DEVIATION 6 | 58 years STANDARD_DEVIATION 6 | 56 years STANDARD_DEVIATION 6 |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 9 Participants | 8 Participants | 35 Participants |
| Sex: Female, Male Male | 10 Participants | 12 Participants | 11 Participants | 12 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Propofol Effect-site Concentration
The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia.
Time frame: Before starting anesthesia to finishing endotracheal intubation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Normal Saline | Propofol Effect-site Concentration | 1.76 ug/ml | Standard Deviation 0.44 |
| Lidocaine | Propofol Effect-site Concentration | 1.14 ug/ml | Standard Deviation 0.35 |
| Bupivacaine | Propofol Effect-site Concentration | 1.09 ug/ml | Standard Deviation 0.39 |
| Ropivacaine | Propofol Effect-site Concentration | 1.04 ug/ml | Standard Deviation 0.18 |
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).
Time frame: Before starting anesthesia to finishing endotracheal intubation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Normal Saline | Bispectral Index Score | Baseline | 96.67 units on a scale | Standard Deviation 1.63 |
| Normal Saline | Bispectral Index Score | 20 minutes after epidural injection | 96.20 units on a scale | Standard Deviation 2.34 |
| Lidocaine | Bispectral Index Score | 20 minutes after epidural injection | 90.00 units on a scale | Standard Deviation 6.33 |
| Lidocaine | Bispectral Index Score | Baseline | 96.70 units on a scale | Standard Deviation 1.49 |
| Bupivacaine | Bispectral Index Score | Baseline | 97.07 units on a scale | Standard Deviation 1.41 |
| Bupivacaine | Bispectral Index Score | 20 minutes after epidural injection | 92.43 units on a scale | Standard Deviation 4.47 |
| Ropivacaine | Bispectral Index Score | Baseline | 96.94 units on a scale | Standard Deviation 1.18 |
| Ropivacaine | Bispectral Index Score | 20 minutes after epidural injection | 89.12 units on a scale | Standard Deviation 5.61 |
Secondary
Heart Rate
The heart rate of each patient was recorded at five different time points
Time frame: Before starting anesthesia to finishing endotracheal intubation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Normal Saline | Heart Rate | Before endotracheal intubation | 64.15 beats per minute | Standard Deviation 9.33 |
| Normal Saline | Heart Rate | 20 minites after epidural injection | 73.95 beats per minute | Standard Deviation 10.94 |
| Normal Saline | Heart Rate | After endotracheal intubation | 88.00 beats per minute | Standard Deviation 12.59 |
| Normal Saline | Heart Rate | Loss of consciousness | 69.90 beats per minute | Standard Deviation 8.67 |
| Normal Saline | Heart Rate | Baseline | 71.70 beats per minute | Standard Deviation 9.53 |
| Lidocaine | Heart Rate | Loss of consciousness | 70.40 beats per minute | Standard Deviation 11.13 |
| Lidocaine | Heart Rate | Before endotracheal intubation | 61.75 beats per minute | Standard Deviation 12.93 |
| Lidocaine | Heart Rate | After endotracheal intubation | 76.70 beats per minute | Standard Deviation 14.24 |
| Lidocaine | Heart Rate | 20 minites after epidural injection | 69.15 beats per minute | Standard Deviation 7.81 |
| Lidocaine | Heart Rate | Baseline | 69.65 beats per minute | Standard Deviation 8.66 |
| Bupivacaine | Heart Rate | Loss of consciousness | 65.90 beats per minute | Standard Deviation 7.25 |
| Bupivacaine | Heart Rate | Baseline | 69.00 beats per minute | Standard Deviation 8.71 |
| Bupivacaine | Heart Rate | 20 minites after epidural injection | 67.40 beats per minute | Standard Deviation 8.91 |
| Bupivacaine | Heart Rate | Before endotracheal intubation | 59.10 beats per minute | Standard Deviation 7.63 |
| Bupivacaine | Heart Rate | After endotracheal intubation | 75.10 beats per minute | Standard Deviation 10.67 |
| Ropivacaine | Heart Rate | Before endotracheal intubation | 61.85 beats per minute | Standard Deviation 8.54 |
| Ropivacaine | Heart Rate | 20 minites after epidural injection | 71.50 beats per minute | Standard Deviation 11.88 |
| Ropivacaine | Heart Rate | Baseline | 74.80 beats per minute | Standard Deviation 13.6 |
| Ropivacaine | Heart Rate | Loss of consciousness | 70.00 beats per minute | Standard Deviation 9.35 |
| Ropivacaine | Heart Rate | After endotracheal intubation | 79.45 beats per minute | Standard Deviation 10.99 |
Secondary
Mean Arterial Pressure
The mean arterial pressure of each patient was recorded at five different time points
Time frame: Before starting anesthesia to finishing endotracheal intubation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Normal Saline | Mean Arterial Pressure | Loss of consciousness | 86.75 mmHg | Standard Deviation 16.68 |
| Normal Saline | Mean Arterial Pressure | 20minites after epidural injection | 99.55 mmHg | Standard Deviation 14.65 |
| Normal Saline | Mean Arterial Pressure | Baseline | 96.40 mmHg | Standard Deviation 13.82 |
| Normal Saline | Mean Arterial Pressure | Before endotracheal intubation | 67.15 mmHg | Standard Deviation 12.87 |
| Normal Saline | Mean Arterial Pressure | After endotracheal intubation | 96.82 mmHg | Standard Deviation 17.57 |
| Lidocaine | Mean Arterial Pressure | 20minites after epidural injection | 96.25 mmHg | Standard Deviation 10.95 |
| Lidocaine | Mean Arterial Pressure | After endotracheal intubation | 84.68 mmHg | Standard Deviation 16.25 |
| Lidocaine | Mean Arterial Pressure | Baseline | 99.65 mmHg | Standard Deviation 12.41 |
| Lidocaine | Mean Arterial Pressure | Loss of consciousness | 81.15 mmHg | Standard Deviation 7.53 |
| Lidocaine | Mean Arterial Pressure | Before endotracheal intubation | 62.30 mmHg | Standard Deviation 12.05 |
| Bupivacaine | Mean Arterial Pressure | Baseline | 98.95 mmHg | Standard Deviation 11.92 |
| Bupivacaine | Mean Arterial Pressure | Before endotracheal intubation | 61.65 mmHg | Standard Deviation 8.72 |
| Bupivacaine | Mean Arterial Pressure | After endotracheal intubation | 85.82 mmHg | Standard Deviation 10.63 |
| Bupivacaine | Mean Arterial Pressure | 20minites after epidural injection | 95.90 mmHg | Standard Deviation 10.95 |
| Bupivacaine | Mean Arterial Pressure | Loss of consciousness | 81.05 mmHg | Standard Deviation 9.19 |
| Ropivacaine | Mean Arterial Pressure | After endotracheal intubation | 86.12 mmHg | Standard Deviation 12.83 |
| Ropivacaine | Mean Arterial Pressure | Loss of consciousness | 80.95 mmHg | Standard Deviation 12.87 |
| Ropivacaine | Mean Arterial Pressure | 20minites after epidural injection | 95.40 mmHg | Standard Deviation 1.94 |
| Ropivacaine | Mean Arterial Pressure | Before endotracheal intubation | 60.60 mmHg | Standard Deviation 7.97 |
| Ropivacaine | Mean Arterial Pressure | Baseline | 98.25 mmHg | Standard Deviation 13.14 |