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| ID | Type | Description | Link |
|---|---|---|---|
| GCP-2005-087 | |||
| KF 02 284302 |
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An accurate dosage of anesthetics during surgery is important. Usually this is achieved through close observation of the patient, but a new monitor (CSM-monitor) can measure the level of anesthesia more closely.
In obese patients dosage of drugs is difficult due to the change in body composition. The CSM-monitor may provide a more accurate dosage of propofol (an anesthetic agent) during surgery, and as a consequence of that, also reduce the postoperative need for analgesics.
Main objective: To optimise propofol dosing in obese patients undergoing hysterectomy.
Main hypothesis: Monitoring the depth of anesthesia using the CSM-monitor reduces time to opening eyes in obese patients after hysterectomy in propofol anesthesia.
Secondary hypotheses: CSM-monitoring reduce propofol dose in obese patients undergoing hysterectomy. Patients with a high CSM-level during hysterectomy have higher postoperative consumption of analgesics. Supplementary, an algorithm for the dose of propofol that most frequently results in a CSM-level between 40 and 60 is calculated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | General anesthesia titrated according to a cerebral state monitor |
|
| B | Active Comparator | General anesthesia titrated according to usual clinical criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to opening eyes in obese patients after hysterectomy in propofol anaesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Propofol dose in obese patients undergoing hysterectomy. | ||
| Postoperative consumption of analgesics. | 24 h after surgery | |
| The algorithm for the dose of propofol that most frequently results in a CSM-level between 40 and 60. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars S. Rasmussen, MD, PhD | Department of anesthesia, 4231, Center of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesia, Juliane Marie Centre, Copenhagen University Hospital Rigshospitalet | Copenhagen | DK-2100 | Denmark | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19173688 | Result | Meyhoff CS, Henneberg SW, Jorgensen BG, Gatke MR, Rasmussen LS. Depth of anaesthesia monitoring in obese patients: a randomized study of propofol-remifentanil. Acta Anaesthesiol Scand. 2009 Mar;53(3):369-75. doi: 10.1111/j.1399-6576.2008.01872.x. Epub 2009 Jan 23. |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Department of Anaesthesia, Copenhagen University Hospital Herlev |
| Herlev |
| DK-2730 |
| Denmark |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |