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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | stopping of propofol and remifentanil infusion | |
| Remifentanil | Active Comparator | stopping of propofol and maintenance of remifentanil infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil | Drug | Control group : stopping of propofol and remifentanil infusion Remifentanil group : stopping of propofol and maintenance of remifentanil infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Arterial Pressure Changes During Extubation | 10 min | |
| HR Changes During Extubation | 10 min | |
| 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). | 2 min |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Awake | Time of BIS > 80 : time between 'stopping of propofol' | 1 hour |
| Time of Extubation | Time of extubation : time between 'stopping of propofol' and 'extubation' |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine | Seoul | 120-752 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | stopping of propofol and remifentanil infusion |
| FG001 | Remifentanil | stopping of propofol and maintenance of remifentanil infusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | stopping of propofol and remifentanil infusion |
| BG001 | Remifentanil | stopping of propofol and maintenance of remifentanil infusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Arterial Pressure Changes During Extubation | Posted | Mean | Standard Deviation | mmHg | 10 min |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | stopping of propofol and remifentanil infusion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shin Ok Koh | Department of Anaesthesiology and Pain Medicine and Anaesthesia and Pain Research Institute, Yonsei University College of Medicine | 82-2-2228-2420 | sokoh@yuhs.ac |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| 1 hr |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Time of Awake | Time of BIS > 80 : time between 'stopping of propofol' | Posted | Median | Full Range | min | 1 hour |
|
|
|
| Primary | HR Changes During Extubation | Posted | Mean | Standard Deviation | beat/min | 10 min |
|
|
|
| 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). | Posted | Number | participants | 2 min |
|
|
|
| Secondary | Time of Extubation | Time of extubation : time between 'stopping of propofol' and 'extubation' | Posted | Median | Full Range | min | 1 hr |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Remifentanil | stopping of propofol and maintenance of remifentanil infusion | 0 | 25 | 0 | 25 |
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| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 2 |
|
| 3 |
|