Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery (Free4Flow)
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ClinicalTrials.gov Identifier: NCT01418118 |
Recruitment Status :
Completed
First Posted : August 16, 2011
Last Update Posted : August 16, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Oral Cancer Head and Neck Cancer Free Flap Hypotension | Drug: Epinephrine Drug: Norepinephrine Drug: Dobutamine Drug: Dopexamine | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | An Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery: A Randomised Study |
Study Start Date : | October 2008 |
Actual Primary Completion Date : | February 2010 |
Actual Study Completion Date : | February 2010 |

Arm | Intervention/treatment |
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Experimental: Pressors
Epinephrine, Norepinephrine, Dobutamine, Dopexamine
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Drug: Epinephrine
0.2mcg/kg/min maximum infusion; to increase mean arterial pressure by 30mmHg Drug: Norepinephrine Maximum infusion of 0.2mcg/kg/min, to increase mean arterial pressure by 30mmHg Drug: Dobutamine Maximum infusion rate of 8mcg/kg/min to increase mean arterial pressure by 30mmHg Drug: Dopexamine Maximum infusion rate of 5mcg/kg/min to increase mean arterial pressure by 30mmHg |
- Absolute change in transfer function (flap vascular resistance) after pressor infusion. [ Time Frame: Post infusion (at 4 hours) ]
- Relative change in transfer function after pressor infusion compared with "normal" tissue. [ Time Frame: Post infusion (at 4 hours) ]
- Change in flap flow after pressor infusion [ Time Frame: Post infusion (at 4 hours) ]
- Differences in frequency spectrum of skin blood flow between flaps and "normal" tissue before and after pressor infusion. [ Time Frame: Post infusion (at 4 hours) ]

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Ages Eligible for Study: | 17 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients undergoing free tissue transfer surgery at the John Radcliffe Hospital wih planned post-operative admission to the intensive care unit.
Exclusion Criteria:
- Pregnancy
- Weight >100kg
- Contraindications to pressor infusions
- Overnight ventilation not indicated

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418118
United Kingdom | |
John Radcliffe Hospital | |
Oxford, Oxfordshire, United Kingdom, OX3 9DU |
Principal Investigator: | Stephen R Watt-Smith, FDSRCS, MD | Oxford University Hospitals NHS Trust |
Responsible Party: | Mr SR Watt-Smith, Oxford Radcliffe Hospitals NHS Trust |
ClinicalTrials.gov Identifier: | NCT01418118 |
Other Study ID Numbers: |
2008-000073-37 5579 2008 000073 37 ( EudraCT Number ) 08/H0606/31 ( Other Identifier: Oxfordshire Research Ethics Committee ) |
First Posted: | August 16, 2011 Key Record Dates |
Last Update Posted: | August 16, 2011 |
Last Verified: | August 2011 |
noradrenaline norepinephrine epinephrine adrenaline dobutamine dopexamine inotrope |
pressor sympathomimetic free flap transplantation free tissue transfer microsurgery survival |
Mouth Neoplasms Hypotension Head and Neck Neoplasms Neoplasms by Site Neoplasms Vascular Diseases Cardiovascular Diseases Mouth Diseases Stomatognathic Diseases Dobutamine Epinephrine Norepinephrine Dopexamine Adrenergic alpha-Agonists Adrenergic Agonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic beta-Agonists Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Mydriatics Sympathomimetics Vasoconstrictor Agents Cardiotonic Agents Adrenergic beta-1 Receptor Agonists |