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The purpose of the study is to test the effects of metoprolol on anaesthesia and the need for perioperative analgesics in patients undergoing breast surgery. With 12 months follow-up the incidence of pain and life satisfaction will be evaluated.
The purpose of the study is to test the effects of intraoperative metoprolol on 1) anaesthetic and alagesic use 2) pain during the early postoperative period and 3) the incidence of pain and lide satisfaction up to 12 months after the surgery. Adverse effects will be recorded as safety measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metoprolol | Experimental | Metoprolol infusion |
|
| Normal saline | Placebo Comparator | Equal volume of saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoprolol | Drug | Intraoperative metoprolol infusion. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Anaesthesia | Total consumption of desflurane | Intraoperative |
| Anaesthesia | Total consumption of remifentanil | Intraoperative |
| Postoperative pain | Total analgesics consumption | First 4 postoperative hours |
| Postoperative pain | Time to analgesics | First 4 postoperative hours |
| Postoperative pain | Numerical pain scale (0 = no pain, 10 = most pain) at rest and at movement | First 4 postoperative hours |
| Long-term pain | The incidence and the level of pain at 3 months | 3 months |
| Long-term pain | The incidence and the level of pain at 12 months | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Number of patients with adverse effects | Perioperative |
| Distribution to the central nervous system | Cerebro spinal fluid and blood samples |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008790 | Metoprolol |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| Normal saline | Drug | Equal of volume compared to metoprolol. |
|
|
| Perioperative |
| Life satisfaction | Life satisfaction in a Likerts scale | 1 year |
| Anxiety | Spielberg State-Trait Anxiety Inventory | 1 year |
| Depression | Beck Depression Inventory | 1 year |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |