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Patients scheduled for elective cardiac surgery are preoperative evaluated using different personality type, stress and anxiety tests.
Patient are randomized to receive the investigators' standard moderate dose sufentanil (bolus 1microgram/kg and propofol 0.03 mg/kg/min) or low dose sufentanil (bolus 0.5 microgram/kg and propofol 0.06 mg/kg/min).
Patients randomized and the type of induction informed to the anaesthetist 30 minutes before surgery.
Patients are monitored before induction of anesthesia. Propofol is started on the randomized infusion rate. Sufentanil bolus are given according to randomization. BIS level is followed. Time to reach BIS < 50 is monitored. BIS after 30, 60 and 90 minutes are registered. Lowest BIS during surgery are registered. Total amounts of sufentanil and propofol recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sufentanil I | Active Comparator | Randomized arm "moderate" sufentanil I: bolus 1 microgram/kg propofol I: infusion 0.03 mg/kg/min |
|
| Sufentanil II | Active Comparator | Randomized arm "low" sufentanil II bolus 0.5 microgram/kg propofol II: infusion 0.06 mg/kg/min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sufentanil I | Drug | bolus dose of sufentanil 1 microgram/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Association between preoperative personality/stress/anxiety and time (minutes) to reach anaesthetic depth goal by bi-spectral index (BIS) | Minutes to reach BIS 50 | Up to 30 minutes |
| Potential of sufentanil regime on fast-track measured by ventilation time and association with eligible discharge from intensive care unit. | Postoperative ventilation time (hours/minutes) and the association to eligible discharge from ICU. | Up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Sufentanil regime and association to haemodynamic parameters (blood pressures, heart rate, cardiac output, oxygenation) | Perioperative changes in haemodynamic parameters (analysis of varians) of haemodynamic parameters according to sufentanil regime | up to 24 hours |
| Association between preoperative personality/stress/anxiety tests and postoperative care using postoperative quality score |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 18, 2022 | |
| Reset | Mar 17, 2022 | |
| Release | Mar 28, 2022 | |
| Reset | Apr 19, 2022 | |
| Release | Jul 20, 2022 | |
| Reset | Aug 17, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 18, 2022 | Mar 17, 2022 | |||
| Mar 28, 2022 |
| ID | Term |
|---|---|
| D017409 | Sufentanil |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Sufentanil II | Drug | bolus dose of sufentanil 0.5 microgram/kg |
|
|
| Propofol I | Drug | Continued dose of propofol 0.03 mg/kg/min |
|
|
| Propofol II | Drug | Continued dose of propofol 0.06 mg/kg/min |
|
|
Association of preoperative tests and the postoperative ICU quality scoring |
| up to 24 hours |
| Association between preoperative personality/stress/anxiety and total amounts of sufentanil and propofol | Amounts of drugs as pr kg pr time unit of involved drugs | Up to 12 hours |
| Apr 19, 2022 |
| Jul 20, 2022 | Aug 17, 2022 |
| D010636 |
| Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |