Target Controlled Infusion (TCI), Thoracic Epidural Anesthesia, Block Level, Gastrointestinal Surgery
Conditions
Keywords
effect-site concentration, propofol, thoracic epidural anesthesia
Brief summary
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.
Interventions
DRUG1% lidocaine
epidural anesthesia with 1% lidocaine 10ml before propofol TCI
DRUG2% lidocaine
epidural anesthesia with 2% lidocaine 5ml before propofol TCI
DRUG0.9% normal saline
epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
Sponsors
First Hospital of China Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) I-II physical status, * aged 40-60 yr, * BMI 19-25 kg/m2, * undergoing elective gastrointestinal surgery
Exclusion criteria
* patients with cardiovascular or neurological disease, drug or alcohol abuse and absolute contraindications for neuraxial blockade.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Effect-site Concentration of Propofol | The participants will be followed for the duration of anesthesia induction, an expected average of half an hour | The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Bispectral Index | The participants will be followed for the duration of anesthesia induction, an expected average of half an hour | 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). |
| The Mean Blood Pressure | The participants will be followed for the duration of anesthesia induction, an expected average of half an hour | 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 Heart Rate | The participants will be followed for the duration of anesthesia induction, an expected average of half an hour | 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 Block Level of Epidural Anesthesia | 20 mins after 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). |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1% Lidocaine epidural anesthesia with 1% lidocaine 10ml before propofol TCI | 15 |
| 2% Lidocaine epidural anesthesia with 2% lidocaine 5ml before propofol TCI | 15 |
| 0.9% Normal Saline epidural anesthesia with 0.9% normal saline 5ml before propofol TCI | 15 |
| Total | 45 |
Baseline characteristics
| Characteristic | 1% Lidocaine | 2% Lidocaine | 0.9% Normal Saline | Total |
|---|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 6 | 57 years STANDARD_DEVIATION 7 | 56 years STANDARD_DEVIATION 4 | 56 years STANDARD_DEVIATION 6 |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 7 Participants | 20 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 8 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
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.
Time frame: The participants will be followed for the duration of anesthesia induction, an expected average of half an hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Lidocaine | The Effect-site Concentration of Propofol | 1.51 µg/ml | Standard Deviation 0.44 |
| 2% Lidocaine | The Effect-site Concentration of Propofol | 1.99 µg/ml | Standard Deviation 0.37 |
| 0.9% Normal Saline | The Effect-site Concentration of Propofol | 2.68 µg/ml | Standard Deviation 0.68 |
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).
Time frame: The participants will be followed for the duration of anesthesia induction, an expected average of half an hour
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1% Lidocaine | The Bispectral Index | Baseline | 95.4 units on a scale | Standard Deviation 1.4 |
| 1% Lidocaine | The Bispectral Index | 10mins after epidural aneasthesia | 85.3 units on a scale | Standard Deviation 0.7 |
| 1% Lidocaine | The Bispectral Index | 20mins after epidural aneasthesia | 84.6 units on a scale | Standard Deviation 0.9 |
| 1% Lidocaine | The Bispectral Index | Loss of consciousness | 65.7 units on a scale | Standard Deviation 0.8 |
| 2% Lidocaine | The Bispectral Index | Loss of consciousness | 65.3 units on a scale | Standard Deviation 2.5 |
| 2% Lidocaine | The Bispectral Index | Baseline | 95.4 units on a scale | Standard Deviation 1.4 |
| 2% Lidocaine | The Bispectral Index | 20mins after epidural aneasthesia | 83.8 units on a scale | Standard Deviation 0.8 |
| 2% Lidocaine | The Bispectral Index | 10mins after epidural aneasthesia | 85.1 units on a scale | Standard Deviation 1.3 |
| 0.9% Normal Saline | The Bispectral Index | Loss of consciousness | 66.1 units on a scale | Standard Deviation 2.6 |
| 0.9% Normal Saline | The Bispectral Index | 10mins after epidural aneasthesia | 94.5 units on a scale | Standard Deviation 0.9 |
| 0.9% Normal Saline | The Bispectral Index | 20mins after epidural aneasthesia | 94.9 units on a scale | Standard Deviation 1.8 |
| 0.9% Normal Saline | The Bispectral Index | Baseline | 95.7 units on a scale | Standard Deviation 1.3 |
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).
Time frame: 20 mins after epidural anesthesia
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Lidocaine | The Block Level of Epidural Anesthesia | 6.5 units on a scale | Standard Deviation 1 |
| 2% Lidocaine | The Block Level of Epidural Anesthesia | 4.2 units on a scale | Standard Deviation 0.9 |
| 0.9% Normal Saline | The Block Level of Epidural Anesthesia | 0 units on a scale | Standard Deviation 0 |
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).
Time frame: The participants will be followed for the duration of anesthesia induction, an expected average of half an hour
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1% Lidocaine | The Heart Rate | Baseline | 71.4 beats per minute | Standard Deviation 4.7 |
| 1% Lidocaine | The Heart Rate | 10mins after epidural aneasthesia | 69.8 beats per minute | Standard Deviation 4.4 |
| 1% Lidocaine | The Heart Rate | 20mins after epidural aneasthesia | 68.5 beats per minute | Standard Deviation 3.4 |
| 1% Lidocaine | The Heart Rate | Loss of consciousness | 63.2 beats per minute | Standard Deviation 1.8 |
| 2% Lidocaine | The Heart Rate | Loss of consciousness | 62.3 beats per minute | Standard Deviation 1.9 |
| 2% Lidocaine | The Heart Rate | Baseline | 72.8 beats per minute | Standard Deviation 3.3 |
| 2% Lidocaine | The Heart Rate | 20mins after epidural aneasthesia | 67.2 beats per minute | Standard Deviation 3.4 |
| 2% Lidocaine | The Heart Rate | 10mins after epidural aneasthesia | 69.2 beats per minute | Standard Deviation 3.7 |
| 0.9% Normal Saline | The Heart Rate | Loss of consciousness | 63.2 beats per minute | Standard Deviation 1.8 |
| 0.9% Normal Saline | The Heart Rate | 10mins after epidural aneasthesia | 71.3 beats per minute | Standard Deviation 3.5 |
| 0.9% Normal Saline | The Heart Rate | 20mins after epidural aneasthesia | 70.3 beats per minute | Standard Deviation 3.3 |
| 0.9% Normal Saline | The Heart Rate | Baseline | 71.3 beats per minute | Standard Deviation 3.5 |
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).
Time frame: The participants will be followed for the duration of anesthesia induction, an expected average of half an hour
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1% Lidocaine | The Mean Blood Pressure | Baseline | 95.4 mmHg | Standard Deviation 2.5 |
| 1% Lidocaine | The Mean Blood Pressure | 10mins after epidural aneasthesia | 85.9 mmHg | Standard Deviation 3.6 |
| 1% Lidocaine | The Mean Blood Pressure | 20mins after epidural aneasthesia | 79.3 mmHg | Standard Deviation 2.5 |
| 1% Lidocaine | The Mean Blood Pressure | Loss of consciousness | 74.0 mmHg | Standard Deviation 1.4 |
| 2% Lidocaine | The Mean Blood Pressure | Loss of consciousness | 74.5 mmHg | Standard Deviation 1 |
| 2% Lidocaine | The Mean Blood Pressure | Baseline | 95.1 mmHg | Standard Deviation 2.1 |
| 2% Lidocaine | The Mean Blood Pressure | 20mins after epidural aneasthesia | 80.5 mmHg | Standard Deviation 3 |
| 2% Lidocaine | The Mean Blood Pressure | 10mins after epidural aneasthesia | 83.7 mmHg | Standard Deviation 2.6 |
| 0.9% Normal Saline | The Mean Blood Pressure | Loss of consciousness | 82.7 mmHg | Standard Deviation 1.3 |
| 0.9% Normal Saline | The Mean Blood Pressure | 10mins after epidural aneasthesia | 95.5 mmHg | Standard Deviation 2.7 |
| 0.9% Normal Saline | The Mean Blood Pressure | 20mins after epidural aneasthesia | 96.1 mmHg | Standard Deviation 2.2 |
| 0.9% Normal Saline | The Mean Blood Pressure | Baseline | 95.9 mmHg | Standard Deviation 2.3 |