Trial Outcomes & Findings for Effects of Epidural Local Anesthetics on Propofol Induction (NCT NCT02000973)
NCT ID: NCT02000973
Last Updated: 2014-05-16
Results Overview
The effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
80 participants
Primary outcome timeframe
Before starting anesthesia to finishing endotracheal intubation
Results posted on
2014-05-16
Participant Flow
Participant milestones
| Measure |
Normal Saline
General anesthesia combined with thoracic epidural 0.9% normal saline
|
Lidocaine
General anesthesia combined with thoracic epidural 1% lidocaine
|
Bupivacaine
General anesthesia combined with thoracic epidural 0.25% bupivacaine
|
Ropivacaine
General anesthesia combined with thoracic epidural 0.3% ropivacaine
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Epidural Local Anesthetics on Propofol Induction
Baseline characteristics by cohort
| Measure |
Normal Saline
n=20 Participants
General anesthesia combined with thoracic epidural 0.9% normal saline
|
Lidocaine
n=20 Participants
General anesthesia combined with thoracic epidural 1% lidocaine
|
Bupivacaine
n=20 Participants
General anesthesia combined with thoracic epidural 0.25% bupivacaine
|
Ropivacaine
n=20 Participants
General anesthesia combined with thoracic epidural 0.3% ropivacaine
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 6 • n=5 Participants
|
57 years
STANDARD_DEVIATION 6 • n=7 Participants
|
57 years
STANDARD_DEVIATION 6 • n=5 Participants
|
58 years
STANDARD_DEVIATION 6 • n=4 Participants
|
56 years
STANDARD_DEVIATION 6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Before starting anesthesia to finishing endotracheal intubationThe effect-site concentration of propofol when loss of consciousness during propofol target-controlled infusing(TCI) induction of anesthesia.
Outcome measures
| Measure |
Normal Saline
n=20 Participants
General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
|
Lidocaine
n=20 Participants
General anesthesia combined with thoracic epidural 1% lidocaine 8ml
|
Bupivacaine
n=20 Participants
General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
|
Ropivacaine
n=20 Participants
General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
|
|---|---|---|---|---|
|
Propofol Effect-site Concentration
|
1.76 ug/ml
Standard Deviation 0.44
|
1.14 ug/ml
Standard Deviation 0.35
|
1.09 ug/ml
Standard Deviation 0.39
|
1.04 ug/ml
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: Before starting anesthesia to finishing endotracheal intubationThe mean arterial pressure of each patient was recorded at five different time points
Outcome measures
| Measure |
Normal Saline
n=20 Participants
General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
|
Lidocaine
n=20 Participants
General anesthesia combined with thoracic epidural 1% lidocaine 8ml
|
Bupivacaine
n=20 Participants
General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
|
Ropivacaine
n=20 Participants
General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
|
|---|---|---|---|---|
|
Mean Arterial Pressure
Baseline
|
96.40 mmHg
Standard Deviation 13.82
|
99.65 mmHg
Standard Deviation 12.41
|
98.95 mmHg
Standard Deviation 11.92
|
98.25 mmHg
Standard Deviation 13.14
|
|
Mean Arterial Pressure
20minites after epidural injection
|
99.55 mmHg
Standard Deviation 14.65
|
96.25 mmHg
Standard Deviation 10.95
|
95.90 mmHg
Standard Deviation 10.95
|
95.40 mmHg
Standard Deviation 1.94
|
|
Mean Arterial Pressure
Loss of consciousness
|
86.75 mmHg
Standard Deviation 16.68
|
81.15 mmHg
Standard Deviation 7.53
|
81.05 mmHg
Standard Deviation 9.19
|
80.95 mmHg
Standard Deviation 12.87
|
|
Mean Arterial Pressure
Before endotracheal intubation
|
67.15 mmHg
Standard Deviation 12.87
|
62.30 mmHg
Standard Deviation 12.05
|
61.65 mmHg
Standard Deviation 8.72
|
60.60 mmHg
Standard Deviation 7.97
|
|
Mean Arterial Pressure
After endotracheal intubation
|
96.82 mmHg
Standard Deviation 17.57
|
84.68 mmHg
Standard Deviation 16.25
|
85.82 mmHg
Standard Deviation 10.63
|
86.12 mmHg
Standard Deviation 12.83
|
SECONDARY outcome
Timeframe: Before starting anesthesia to finishing endotracheal intubationThe heart rate of each patient was recorded at five different time points
Outcome measures
| Measure |
Normal Saline
n=20 Participants
General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
|
Lidocaine
n=20 Participants
General anesthesia combined with thoracic epidural 1% lidocaine 8ml
|
Bupivacaine
n=20 Participants
General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
|
Ropivacaine
n=20 Participants
General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
|
|---|---|---|---|---|
|
Heart Rate
Before endotracheal intubation
|
64.15 beats per minute
Standard Deviation 9.33
|
61.75 beats per minute
Standard Deviation 12.93
|
59.10 beats per minute
Standard Deviation 7.63
|
61.85 beats per minute
Standard Deviation 8.54
|
|
Heart Rate
Baseline
|
71.70 beats per minute
Standard Deviation 9.53
|
69.65 beats per minute
Standard Deviation 8.66
|
69.00 beats per minute
Standard Deviation 8.71
|
74.80 beats per minute
Standard Deviation 13.60
|
|
Heart Rate
20 minites after epidural injection
|
73.95 beats per minute
Standard Deviation 10.94
|
69.15 beats per minute
Standard Deviation 7.81
|
67.40 beats per minute
Standard Deviation 8.91
|
71.50 beats per minute
Standard Deviation 11.88
|
|
Heart Rate
Loss of consciousness
|
69.90 beats per minute
Standard Deviation 8.67
|
70.40 beats per minute
Standard Deviation 11.13
|
65.90 beats per minute
Standard Deviation 7.25
|
70.00 beats per minute
Standard Deviation 9.35
|
|
Heart Rate
After endotracheal intubation
|
88.00 beats per minute
Standard Deviation 12.59
|
76.70 beats per minute
Standard Deviation 14.24
|
75.10 beats per minute
Standard Deviation 10.67
|
79.45 beats per minute
Standard Deviation 10.99
|
SECONDARY outcome
Timeframe: Before starting anesthesia to finishing endotracheal intubationThe 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).
Outcome measures
| Measure |
Normal Saline
n=20 Participants
General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
|
Lidocaine
n=20 Participants
General anesthesia combined with thoracic epidural 1% lidocaine 8ml
|
Bupivacaine
n=20 Participants
General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
|
Ropivacaine
n=20 Participants
General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
|
|---|---|---|---|---|
|
Bispectral Index Score
Baseline
|
96.67 units on a scale
Standard Deviation 1.63
|
96.70 units on a scale
Standard Deviation 1.49
|
97.07 units on a scale
Standard Deviation 1.41
|
96.94 units on a scale
Standard Deviation 1.18
|
|
Bispectral Index Score
20 minutes after epidural injection
|
96.20 units on a scale
Standard Deviation 2.34
|
90.00 units on a scale
Standard Deviation 6.33
|
92.43 units on a scale
Standard Deviation 4.47
|
89.12 units on a scale
Standard Deviation 5.61
|
Adverse Events
Normal Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lidocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ropivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place