Trial Outcomes & Findings for Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy (NCT NCT01470170)
NCT ID: NCT01470170
Last Updated: 2015-08-13
Results Overview
After the administration of alfentanil and propofol, the effect site concentration was recorded at the time when the consciousness level reaches observer assessment of alertness and sedation scale 3 (OAAS-3). The effect site concentration is the concentration of drug propofol in brain calculated by TCI using Schnider model.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
173 participants
Primary outcome timeframe
All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hours
Results posted on
2015-08-13
Participant Flow
Participant milestones
| Measure |
Group1
Alfentanil 2.5μg/kg immediately before TCI propofol administration
|
Group2
Alfentanil 5μg/kg immediately before TCI propofol administration
|
Group 3
Alfentanil 2.5μg/kg two minutes before TCI propofol administration
|
Group 4
Alfentanil 5μg/kg two minutes before TCI propofol administration
|
Group 5 Control
TCI propofol administration alone
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
34
|
35
|
34
|
36
|
34
|
|
Overall Study
COMPLETED
|
34
|
35
|
34
|
36
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Regimen of Alfentanil in Propofol Sedative Fibro-bronchoscopy
Baseline characteristics by cohort
| Measure |
Group1
n=34 Participants
alfentanil 2.5ug/kg immediately before propofol
|
Group 2
n=35 Participants
alfentanil 2.5ug/kg two minutes before propofol
|
Group 3
n=34 Participants
alfentanil 5ug/kg immediately before propofol
|
Group 4
n=36 Participants
alfentanil 5ug/kg two minutes before propofol
|
Group 5/ Control
n=34 Participants
Propofol alone
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 15.8 • n=7 Participants
|
58.8 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 13.9 • n=4 Participants
|
62.2 years
STANDARD_DEVIATION 11.1 • n=21 Participants
|
60.5 years
STANDARD_DEVIATION 12.1 • n=10 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
70 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
103 Participants
n=10 Participants
|
|
Body Mass Index
|
23.7 kg/m^2
STANDARD_DEVIATION 2.4 • n=5 Participants
|
23.5 kg/m^2
STANDARD_DEVIATION 3.4 • n=7 Participants
|
23.8 kg/m^2
STANDARD_DEVIATION 4.5 • n=5 Participants
|
23.5 kg/m^2
STANDARD_DEVIATION 3.3 • n=4 Participants
|
23.2 kg/m^2
STANDARD_DEVIATION 3.7 • n=21 Participants
|
23.54 kg/m^2
STANDARD_DEVIATION 3.5 • n=10 Participants
|
|
American Society of Anaethesiology Physical Status Score
1 Normally healthy
|
19 participants
n=5 Participants
|
23 participants
n=7 Participants
|
23 participants
n=5 Participants
|
19 participants
n=4 Participants
|
24 participants
n=21 Participants
|
108 participants
n=10 Participants
|
|
American Society of Anaethesiology Physical Status Score
2 Discrete systemic disease
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
10 participants
n=4 Participants
|
6 participants
n=21 Participants
|
35 participants
n=10 Participants
|
|
American Society of Anaethesiology Physical Status Score
3 Serious, non-incapacitating systemic disease
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
4 participants
n=5 Participants
|
7 participants
n=4 Participants
|
4 participants
n=21 Participants
|
30 participants
n=10 Participants
|
|
Mallampati Score
I: soft palate, uvula, fauces, pillars visible
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
4 participants
n=5 Participants
|
5 participants
n=4 Participants
|
7 participants
n=21 Participants
|
26 participants
n=10 Participants
|
|
Mallampati Score
II: soft palate, uvula, fauces visible
|
16 participants
n=5 Participants
|
13 participants
n=7 Participants
|
14 participants
n=5 Participants
|
10 participants
n=4 Participants
|
12 participants
n=21 Participants
|
65 participants
n=10 Participants
|
|
Mallampati Score
III: soft palate, base of uvula visible
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
16 participants
n=5 Participants
|
21 participants
n=4 Participants
|
15 participants
n=21 Participants
|
82 participants
n=10 Participants
|
|
Regular use of opioid
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
3 participants
n=10 Participants
|
|
Regular use of sedation drugs
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
5 participants
n=4 Participants
|
3 participants
n=21 Participants
|
17 participants
n=10 Participants
|
|
Alcohol use
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
4 participants
n=21 Participants
|
17 participants
n=10 Participants
|
|
smoking status
never
|
20 participants
n=5 Participants
|
18 participants
n=7 Participants
|
21 participants
n=5 Participants
|
19 participants
n=4 Participants
|
20 participants
n=21 Participants
|
98 participants
n=10 Participants
|
|
smoking status
current
|
7 participants
n=5 Participants
|
12 participants
n=7 Participants
|
8 participants
n=5 Participants
|
11 participants
n=4 Participants
|
6 participants
n=21 Participants
|
44 participants
n=10 Participants
|
|
smoking status
ex-
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
6 participants
n=4 Participants
|
8 participants
n=21 Participants
|
31 participants
n=10 Participants
|
|
heart rate
|
80.3 beats/min
STANDARD_DEVIATION 15.5 • n=5 Participants
|
78.1 beats/min
STANDARD_DEVIATION 12.6 • n=7 Participants
|
73.9 beats/min
STANDARD_DEVIATION 14.2 • n=5 Participants
|
80.3 beats/min
STANDARD_DEVIATION 14.5 • n=4 Participants
|
80.2 beats/min
STANDARD_DEVIATION 11.4 • n=21 Participants
|
78.6 beats/min
STANDARD_DEVIATION 14.4 • n=10 Participants
|
|
SBP
|
147.1 mmHg
STANDARD_DEVIATION 24.3 • n=5 Participants
|
139.9 mmHg
STANDARD_DEVIATION 20.5 • n=7 Participants
|
139.2 mmHg
STANDARD_DEVIATION 20.8 • n=5 Participants
|
142.4 mmHg
STANDARD_DEVIATION 21.5 • n=4 Participants
|
145.8 mmHg
STANDARD_DEVIATION 20.5 • n=21 Participants
|
142.9 mmHg
STANDARD_DEVIATION 21.5 • n=10 Participants
|
|
DBP
|
80.8 mmHg
STANDARD_DEVIATION 12.7 • n=5 Participants
|
78.7 mmHg
STANDARD_DEVIATION 13.5 • n=7 Participants
|
76.9 mmHg
STANDARD_DEVIATION 11.8 • n=5 Participants
|
79.5 mmHg
STANDARD_DEVIATION 12.1 • n=4 Participants
|
80.2 mmHg
STANDARD_DEVIATION 11.4 • n=21 Participants
|
79.2 mmHg
STANDARD_DEVIATION 12.2 • n=10 Participants
|
|
SpO2
|
98.8 percentage of saturation
STANDARD_DEVIATION 1.5 • n=5 Participants
|
98.6 percentage of saturation
STANDARD_DEVIATION 1.5 • n=7 Participants
|
99.0 percentage of saturation
STANDARD_DEVIATION 1.4 • n=5 Participants
|
99.2 percentage of saturation
STANDARD_DEVIATION 1.3 • n=4 Participants
|
99.1 percentage of saturation
STANDARD_DEVIATION 1.5 • n=21 Participants
|
98.9 percentage of saturation
STANDARD_DEVIATION 1.4 • n=10 Participants
|
PRIMARY outcome
Timeframe: All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hoursAfter the administration of alfentanil and propofol, the effect site concentration was recorded at the time when the consciousness level reaches observer assessment of alertness and sedation scale 3 (OAAS-3). The effect site concentration is the concentration of drug propofol in brain calculated by TCI using Schnider model.
Outcome measures
| Measure |
Group1
n=34 Participants
alfentanil 2.5ug/kg immediately before propofol
|
Group 2
n=35 Participants
alfentanil 2.5ug/kg two minutes before propofol
|
Group 3
n=34 Participants
alfentanil 5ug/kg immediately before propofol
|
Group 4
n=36 Participants
alfentanil 5ug/kg two minutes before propofol
|
Group 5 /Control
n=34 Participants
Propofol alone
|
|---|---|---|---|---|---|
|
Effect Site Concentration When Conscious Level Reaches OAAS-3
|
2.3 ug/ml
Standard Deviation 0.4
|
2.2 ug/ml
Standard Deviation 0.4
|
2.5 ug/ml
Standard Deviation 0.4
|
2.2 ug/ml
Standard Deviation 0.5
|
2.6 ug/ml
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hoursAfter the administration of Alfentanil and Propofol, the Propofol dose needed to reach conscious level of observer assessment of alertness and sedation scale 3 (OAAS-3) will be recorded.
Outcome measures
| Measure |
Group1
n=34 Participants
alfentanil 2.5ug/kg immediately before propofol
|
Group 2
n=35 Participants
alfentanil 2.5ug/kg two minutes before propofol
|
Group 3
n=34 Participants
alfentanil 5ug/kg immediately before propofol
|
Group 4
n=36 Participants
alfentanil 5ug/kg two minutes before propofol
|
Group 5 /Control
n=34 Participants
Propofol alone
|
|---|---|---|---|---|---|
|
Propofol Dose Needed to Reach Conscious Level OAAS-3
|
67.8 mg
Standard Deviation 56.2
|
56.4 mg
Standard Deviation 29.2
|
75.3 mg
Standard Deviation 37.1
|
54.8 mg
Standard Deviation 29.0
|
76.3 mg
Standard Deviation 31.9
|
PRIMARY outcome
Timeframe: All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hoursAfter the administration of Alfentanil and Propofol, the time period required to reach conscious level OAAS-3 will be recorded.
Outcome measures
| Measure |
Group1
n=34 Participants
alfentanil 2.5ug/kg immediately before propofol
|
Group 2
n=35 Participants
alfentanil 2.5ug/kg two minutes before propofol
|
Group 3
n=34 Participants
alfentanil 5ug/kg immediately before propofol
|
Group 4
n=36 Participants
alfentanil 5ug/kg two minutes before propofol
|
Group 5 /Control
n=34 Participants
Propofol alone
|
|---|---|---|---|---|---|
|
Induction Time, Time Period That Will be Required for Conscious Level to Reach OAAS-3
|
279 second
Standard Deviation 189
|
263 second
Standard Deviation 170
|
374 second
Standard Deviation 203
|
247 second
Standard Deviation 183
|
402 second
Standard Deviation 190
|
SECONDARY outcome
Timeframe: All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hoursCheck the frequency of hypoxemia episode during induction, procedure, and recovery time
Outcome measures
| Measure |
Group1
n=34 Participants
alfentanil 2.5ug/kg immediately before propofol
|
Group 2
n=35 Participants
alfentanil 2.5ug/kg two minutes before propofol
|
Group 3
n=34 Participants
alfentanil 5ug/kg immediately before propofol
|
Group 4
n=36 Participants
alfentanil 5ug/kg two minutes before propofol
|
Group 5 /Control
n=34 Participants
Propofol alone
|
|---|---|---|---|---|---|
|
Hypoxemia
Induction time
|
1 participants
|
9 participants
|
1 participants
|
6 participants
|
1 participants
|
|
Hypoxemia
Procedure time
|
13 participants
|
10 participants
|
16 participants
|
15 participants
|
18 participants
|
|
Hypoxemia
Recovery time
|
5 participants
|
2 participants
|
5 participants
|
4 participants
|
5 participants
|
SECONDARY outcome
Timeframe: All participants wil be follow for the duration of bronchoscope room stay, an expect average of 2 hoursCheck the frequency of hypotension episode during induction, procedure and recovery time
Outcome measures
| Measure |
Group1
n=34 Participants
alfentanil 2.5ug/kg immediately before propofol
|
Group 2
n=35 Participants
alfentanil 2.5ug/kg two minutes before propofol
|
Group 3
n=34 Participants
alfentanil 5ug/kg immediately before propofol
|
Group 4
n=36 Participants
alfentanil 5ug/kg two minutes before propofol
|
Group 5 /Control
n=34 Participants
Propofol alone
|
|---|---|---|---|---|---|
|
Hypotension
Induction time
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Hypotension
Procedure time
|
7 participants
|
7 participants
|
11 participants
|
5 participants
|
6 participants
|
|
Hypotension
Recovery time
|
4 participants
|
4 participants
|
4 participants
|
2 participants
|
4 participants
|
Adverse Events
Group1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 5 /Control
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