Trial Outcomes & Findings for A Low Dose Remifentanil Infusion During Tracheal Extubation in Surgical Intensive Care Unit Patients (NCT NCT01152515)
NCT ID: NCT01152515
Last Updated: 2020-03-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
10 min
Results posted on
2020-03-27
Participant Flow
Participant milestones
| Measure |
Control
stopping of propofol and remifentanil infusion
|
Remifentanil
stopping of propofol and maintenance of remifentanil infusion
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Low Dose Remifentanil Infusion During Tracheal Extubation in Surgical Intensive Care Unit Patients
Baseline characteristics by cohort
| Measure |
Control
n=25 Participants
stopping of propofol and remifentanil infusion
|
Remifentanil
n=25 Participants
stopping of propofol and maintenance of remifentanil infusion
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 14 • n=5 Participants
|
58 years
STANDARD_DEVIATION 13 • n=7 Participants
|
57 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 minOutcome measures
| Measure |
Control
n=25 Participants
stopping of propofol and remifentanil infusion
|
Remifentanil
n=25 Participants
stopping of propofol and maintenance of remifentanil infusion
|
|---|---|---|
|
Mean Arterial Pressure Changes During Extubation
10 min after extubation
|
96 mmHg
Standard Deviation 17
|
97 mmHg
Standard Deviation 13
|
|
Mean Arterial Pressure Changes During Extubation
5 min after extuabtion
|
94 mmHg
Standard Deviation 17
|
97 mmHg
Standard Deviation 13
|
PRIMARY outcome
Timeframe: 10 minOutcome measures
| Measure |
Control
n=25 Participants
stopping of propofol and remifentanil infusion
|
Remifentanil
n=25 Participants
stopping of propofol and maintenance of remifentanil infusion
|
|---|---|---|
|
HR Changes During Extubation
5 min after extubation
|
94 beat/min
Standard Deviation 18
|
95 beat/min
Standard Deviation 13
|
|
HR Changes During Extubation
10 min after extubation
|
94 beat/min
Standard Deviation 17
|
93 beat/min
Standard Deviation 12
|
PRIMARY outcome
Timeframe: 2 minGrade of cough was assessed on a four-point scale (0=no coughing, 1=single cough, 2=more than one episode of nonsustained coughing, 3=sustained and repetitive coughing with head lift).
Outcome measures
| Measure |
Control
n=25 Participants
stopping of propofol and remifentanil infusion
|
Remifentanil
n=25 Participants
stopping of propofol and maintenance of remifentanil infusion
|
|---|---|---|
|
The Grade of Coughing During Extubation
0
|
8 participants
|
11 participants
|
|
The Grade of Coughing During Extubation
1
|
11 participants
|
9 participants
|
|
The Grade of Coughing During Extubation
2
|
4 participants
|
3 participants
|
|
The Grade of Coughing During Extubation
3
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 1 hourTime of BIS \> 80 : time between 'stopping of propofol'
Outcome measures
| Measure |
Control
n=25 Participants
stopping of propofol and remifentanil infusion
|
Remifentanil
n=25 Participants
stopping of propofol and maintenance of remifentanil infusion
|
|---|---|---|
|
Time of Awake
|
3.5 min
Interval 1.0 to 10.0
|
4 min
Interval 1.0 to 10.0
|
SECONDARY outcome
Timeframe: 1 hrTime of extubation : time between 'stopping of propofol' and 'extubation'
Outcome measures
| Measure |
Control
n=25 Participants
stopping of propofol and remifentanil infusion
|
Remifentanil
n=25 Participants
stopping of propofol and maintenance of remifentanil infusion
|
|---|---|---|
|
Time of Extubation
|
8 min
Interval 4.0 to 17.0
|
14 min
Interval 3.0 to 40.0
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Remifentanil
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
Dr. Shin Ok Koh
Department of Anaesthesiology and Pain Medicine and Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
Phone: 82-2-2228-2420
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place