Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003648-31 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine generation of a target controlled infusion model for the patient controlled analgesia with the strong analgesic, hydromorphone, after planned open heart surgery, during which the strong analgesic, sufentanil, was used.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sufentanil Group 1 | Active Comparator | Sufentanil Low Titration |
|
| Sufentanil Group 2 | Active Comparator | Sufentanil High Titration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sufentanil, Hydromorphone | Drug | Intraoperatively: Target controlled infusion with 0.4 ng/ml Sufentanil, Postoperatively: Patient-controlled analgesia with target-controlled infusion of Hydromorphone |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of sufentanil and hydromorphone | 28 blood samples are taken during the study period of 48 hours postoperatively for characterizing the pharmacokinetics | 48 hours |
| Numerical Rating Scale for Clinical Pain | 11 assessments of patient's pain sensation using Numerical Rating Scale for Clinical Pain during patient-controlled analgesia with target-controlled infusion of hydromorphone 8 hours after extubation for characterizing the analgesic effect | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of hydromorphone | Cumulative dose of hydromorphone for patient-controlled analgesia with target-controlled infusion of hydromorphone for characterizing the analgesic requirement | 8 hours |
| Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christian Jeleazcov, MD | Department of Anesthesiology, University Hospital Erlangen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, University Hospital | Erlangen | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23958818 | Background | Jeleazcov C, Saari TI, Ihmsen H, Mell J, Frohlich K, Krajinovic L, Fechner J, Schuttler J. Population pharmacokinetic modeling of hydromorphone in cardiac surgery patients during postoperative pain therapy. Anesthesiology. 2014 Feb;120(2):378-91. doi: 10.1097/ALN.0b013e3182a76d05. | |
| 25001621 | Background | Saari TI, Ihmsen H, Mell J, Frohlich K, Fechner J, Schuttler J, Jeleazcov C. Influence of intensive care treatment on the protein binding of sufentanil and hydromorphone during pain therapy in postoperative cardiac surgery patients. Br J Anaesth. 2014 Oct;113(4):677-87. doi: 10.1093/bja/aeu160. Epub 2014 Jul 6. |
Not provided
Not provided
Not provided
| 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 |
|---|---|
| D017409 | Sufentanil |
| D004091 | Hydromorphone |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sufentanil, Hydromorphone | Drug | Intraoperatively: Target controlled infusion with 0.8 ng/ml Sufentanil, Postoperatively: Patient-controlled analgesia with target-controlled infusion of Hydromorphone |
|
11 assessments of the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) Scale during patient-controlled analgesia with target-controlled infusion of hydromorphone 8 hours after extubation for characterizing the sedation level |
| 8 hours |
| 22884788 | Background | Saari TI, Fechner J, Ihmsen H, Schuttler J, Jeleazcov C. Analysis of total and unbound hydromorphone in human plasma by ultrafiltration and LC-MS/MS: application to clinical trial in patients undergoing open heart surgery. J Pharm Biomed Anal. 2012 Dec;71:63-70. doi: 10.1016/j.jpba.2012.07.025. Epub 2012 Jul 31. |
| 22522038 | Background | Saari TI, Fechner J, Ihmsen H, Schuttler J, Jeleazcov C. Determination of total and unbound sufentanil in human plasma by ultrafiltration and LC-MS/MS: application to clinical pharmacokinetic study. J Pharm Biomed Anal. 2012 Jul;66:306-13. doi: 10.1016/j.jpba.2012.03.050. Epub 2012 Apr 3. |
| D009022 |
| Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |