Tracheal Extubation
Conditions
Keywords
safety and efficacy of maintaining a remifentanil infusion during extubation in propofol-remifentanil sedated patients after surgery
Brief summary
Tracheal extubation can be associated with hyperdynamic circulatory response. The investigators examined the effect of maintaining a remifentanil infusion on the cardiovascular response during extubation in propofol-remifentanil sedated patients after surgery.
Interventions
DRUGRemifentanil
Control group : stopping of propofol and remifentanil infusion Remifentanil group : stopping of propofol and maintenance of remifentanil infusion
Sponsors
Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 20 2. Short term ventilator care after surgery in intensive care unit
Exclusion criteria
1. pneumonia 2. chronic obstructive lung disease 3. asthma 4. end stage renal disease 5. risk factors for aspiration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Arterial Pressure Changes During Extubation | 10 min | — |
| HR Changes During Extubation | 10 min | — |
| The Grade of Coughing During Extubation | 2 min | Grade 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of Awake | 1 hour | Time of BIS \> 80 : time between 'stopping of propofol' |
| Time of Extubation | 1 hr | Time of extubation : time between 'stopping of propofol' and 'extubation' |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control stopping of propofol and remifentanil infusion | 25 |
| Remifentanil stopping of propofol and maintenance of remifentanil infusion | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Remifentanil | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 4 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 21 Participants | 40 Participants |
| Age, Continuous | 58 years STANDARD_DEVIATION 13 | 56 years STANDARD_DEVIATION 14 | 57 years STANDARD_DEVIATION 13 |
| Region of Enrollment Korea, Republic of | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 10 Participants | 13 Participants | 23 Participants |
| Sex: Female, Male Male | 15 Participants | 12 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
HR Changes During Extubation
Time frame: 10 min
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | HR Changes During Extubation | 5 min after extubation | 94 beat/min | Standard Deviation 18 |
| Control | HR Changes During Extubation | 10 min after extubation | 94 beat/min | Standard Deviation 17 |
| Remifentanil | HR Changes During Extubation | 5 min after extubation | 95 beat/min | Standard Deviation 13 |
| Remifentanil | HR Changes During Extubation | 10 min after extubation | 93 beat/min | Standard Deviation 12 |
Primary
Mean Arterial Pressure Changes During Extubation
Time frame: 10 min
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Mean Arterial Pressure Changes During Extubation | 5 min after extuabtion | 94 mmHg | Standard Deviation 17 |
| Control | Mean Arterial Pressure Changes During Extubation | 10 min after extubation | 96 mmHg | Standard Deviation 17 |
| Remifentanil | Mean Arterial Pressure Changes During Extubation | 10 min after extubation | 97 mmHg | Standard Deviation 13 |
| Remifentanil | Mean Arterial Pressure Changes During Extubation | 5 min after extuabtion | 97 mmHg | Standard Deviation 13 |
Primary
The Grade of Coughing During Extubation
Grade 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).
Time frame: 2 min
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | The Grade of Coughing During Extubation | 0 | 8 participants |
| Control | The Grade of Coughing During Extubation | 1 | 11 participants |
| Control | The Grade of Coughing During Extubation | 2 | 4 participants |
| Control | The Grade of Coughing During Extubation | 3 | 2 participants |
| Remifentanil | The Grade of Coughing During Extubation | 3 | 2 participants |
| Remifentanil | The Grade of Coughing During Extubation | 0 | 11 participants |
| Remifentanil | The Grade of Coughing During Extubation | 2 | 3 participants |
| Remifentanil | The Grade of Coughing During Extubation | 1 | 9 participants |
Secondary
Time of Awake
Time of BIS \> 80 : time between 'stopping of propofol'
Time frame: 1 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Time of Awake | 3.5 min |
| Remifentanil | Time of Awake | 4 min |
Secondary
Time of Extubation
Time of extubation : time between 'stopping of propofol' and 'extubation'
Time frame: 1 hr
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Time of Extubation | 8 min |
| Remifentanil | Time of Extubation | 14 min |