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| ID | Type | Description | Link |
|---|---|---|---|
| 2008 000073 37 | EudraCT Number | ||
| 08/H0606/31 | Other Identifier | Oxfordshire Research Ethics Committee |
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Following surgery to remove tumours of the head and neck, patients undergo reconstruction with free flaps - tissue that is taken from elsewhere in the body and given a new blood supply by attaching it to vessels in the neck. Following this type of surgery, patients often need medication to maintain their blood pressure in the intensive care unit. The effect of these drugs on the transplanted tissues is unknown. This study investigates the effects of four commonly used drugs on free flap perfusion.
The optimal sympathomimetic drug to support blood pressure without adverse vasoconstriction of free flap circulation remains unknown. This study examined the effects of four agents (epinephrine, norepinephrine, dobutamine and dopexamine) on free flaps following resection of head and neck cancer.
Twenty five patients were recruited to the study. Each patient received an infusion of the four drugs in a random order with an intervening washout period between drugs, at four infusion rates. Continuous free flap skin blood flow monitoring was performed using laser Doppler velocimetry, with a second sensor on normal skin acting as a control. Global cardiovascular variables were monitored using the LiDCO Rapid pulse contour analysis system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pressors | Experimental | Epinephrine, Norepinephrine, Dobutamine, Dopexamine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epinephrine | Drug | 0.2mcg/kg/min maximum infusion; to increase mean arterial pressure by 30mmHg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in transfer function (flap vascular resistance) after pressor infusion. | Post infusion (at 4 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in transfer function after pressor infusion compared with "normal" tissue. | Post infusion (at 4 hours) | |
| Change in flap flow after pressor infusion | Post infusion (at 4 hours) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen R Watt-Smith, FDSRCS, MD | Oxford University Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Radcliffe Hospital | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22929242 | Derived | Eley KA, Young JD, Watt-Smith SR. Epinephrine, norepinephrine, dobutamine, and dopexamine effects on free flap skin blood flow. Plast Reconstr Surg. 2012 Sep;130(3):564-570. doi: 10.1097/PRS.0b013e31825dbf73. |
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| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| D009638 | Norepinephrine |
| D004280 | Dobutamine |
| C046318 | dopexamine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Norepinephrine |
| Drug |
Maximum infusion of 0.2mcg/kg/min, to increase mean arterial pressure by 30mmHg |
|
| Dobutamine | Drug | Maximum infusion rate of 8mcg/kg/min to increase mean arterial pressure by 30mmHg |
|
| Dopexamine | Drug | Maximum infusion rate of 5mcg/kg/min to increase mean arterial pressure by 30mmHg |
|
| Differences in frequency spectrum of skin blood flow between flaps and "normal" tissue before and after pressor infusion. |
| Post infusion (at 4 hours) |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |