Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to compare the accuracy of the changes in CVI in response to a standardized noxious stimulus during various targeted pseudo-steady-state concentrations of remifentanil and various steady state level of BIS as guided by propofol effect compartment controlled TCI (closed-loop).
Patients will be allocated to receive a specific effect-site concentration of remifentanil and propofol. For remifentanil, concentrations will be targeted at 0, 2, 4 and 6 ng/ml. After an equilibration period, anesthesia will be induced in all patients using propofol in order to reach and maintain a BIS value of 70, 50 or 30. After an equilibration period(from start of propofol infusion), OAA/S will be measured in all patient. All patients will receive a standard pain stimulus (30 seconds, 50 mA) in order to observe the influence of the effect-site concentration of propofol and remifentanil on the CVI. A time window of 5 minutes after the stimulus will be respected to observe the changes in both BIS and CVI. After this period, the study will be terminated and classical maintenance of anesthesia will be provided.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 BIS value 30 | Active Comparator |
| |
| Group 2 BIS value 30 | Active Comparator |
| |
| Group 3 BIS value 30 | Active Comparator |
| |
| Group 4 BIS valaue 30 | Active Comparator |
| |
| Group 1 BIS value 50 | Active Comparator |
| |
| Group 2 BIS value 50 | Active Comparator |
| |
| Group 3 BIS value 50 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| propofol + remifentanil 0 ng/ml | Drug | remifentanil 0 ng/ml |
| |
| Measure | Description | Time Frame |
|---|---|---|
| BIS and CVI. | 2 year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | Provincie Groningen | 9713EZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24892803 | Derived | Sahinovic MM, Eleveld DJ, Kalmar AF, Heeremans EH, De Smet T, Seshagiri CV, Absalom AR, Vereecke HEM, Struys MMRF. Accuracy of the composite variability index as a measure of the balance between nociception and antinociception during anesthesia. Anesth Analg. 2014 Aug;119(2):288-301. doi: 10.1213/ANE.0000000000000274. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Group 4 BIS value 50 | Active Comparator |
|
| Group 1 BIS value 70 | Active Comparator |
|
| Group 2 BIS value 70 | Active Comparator |
|
| Group 3 BIS value 70 | Active Comparator |
|
| Group 4 BIS value 70 | Active Comparator |
|
| propofol + remifentanil 2 ng/ml |
| Drug |
|
| propofol + remifentanil 4 ng/ml | Drug |
|
| propofol + remifentanil 6 ng/ml | Drug |
|
| propofol + remifentanil 0 ng/ml | Drug |
|
| propofol + remifentanil 2 ng/ml | Drug |
|
| propofol + remifentanil 6 ng/ml | Drug |
|
| propofol + remifentanil 6 ng/ml | Drug |
|
| propofol + remifentanil 0 ng/ml | Drug |
|
| propofol + remifentanil 2 ng/ml | Drug |
|
| propofol + remifentanil 4 ng/ml | Drug |
|
| propofol + remifentanil 6 ng/ml | Drug |
|
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided