Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery - Full Text View

Purpose

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.

Condition	Intervention	Phase
Oral Cancer Head and Neck Cancer Free Flap Hypotension	Drug: Epinephrine Drug: Norepinephrine Drug: Dobutamine Drug: Dopexamine	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Norepinephrine bitartrate Norepinephrine Epinephrine bitartrate Epinephrine Epinephrine hydrochloride Racepinephrine hydrochloride Racepinephrine Dobutamine Dobutamine hydrochloride

Genetic and Rare Diseases Information Center resources: Oral Cancer Lip and Oral Cavity Cancer

U.S. FDA Resources

Further study details as provided by Oxford University Hospitals NHS Trust:

Primary Outcome Measures:

Absolute change in transfer function (flap vascular resistance) after pressor infusion. [ Time Frame: Post infusion (at 4 hours) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Relative change in transfer function after pressor infusion compared with "normal" tissue. [ Time Frame: Post infusion (at 4 hours) ] [ Designated as safety issue: No ]
Change in flap flow after pressor infusion [ Time Frame: Post infusion (at 4 hours) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]


Enrollment:	25
Study Start Date:	October 2008
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pressors Epinephrine, Norepinephrine, Dobutamine, Dopexamine	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

Detailed Description:

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.

Eligibility


Ages Eligible for Study:	17 Years and older (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01418118

Locations


United Kingdom
John Radcliffe Hospital
Oxford, Oxfordshire, United Kingdom, OX3 9DU

Sponsors and Collaborators

Oxford University Hospitals NHS Trust

Investigators


Principal Investigator:	Stephen R Watt-Smith, FDSRCS, MD	Oxford University Hospitals NHS Trust

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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):564-70. doi: 10.1097/PRS.0b013e31825dbf73.


Responsible Party:	Mr SR Watt-Smith, Oxford Radcliffe Hospitals NHS Trust
ClinicalTrials.gov Identifier:	NCT01418118 History of Changes
Other Study ID Numbers:	2008-000073-37 5579 2008 000073 37 08/H0606/31
Study First Received:	August 15, 2011
Last Updated:	August 15, 2011
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: National Health Service United Kingdom: Research Ethics Committee

Keywords provided by Oxford University Hospitals NHS Trust:


noradrenaline norepinephrine epinephrine adrenaline dobutamine dopexamine inotrope	pressor sympathomimetic free flap transplantation free tissue transfer microsurgery survival

Additional relevant MeSH terms:


Head and Neck Neoplasms Hypotension Mouth Neoplasms Neoplasms by Site Neoplasms Vascular Diseases Cardiovascular Diseases Mouth Diseases Stomatognathic Diseases Epinephrine Racepinephrine Norepinephrine Dobutamine Dopexamine Epinephryl borate	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

ClinicalTrials.gov processed this record on September 26, 2016

Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery (Free4Flow)