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

Information source: Oxford University Hospitals NHS Trust
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Oral Cancer; Head and Neck Cancer; Free Flap; Hypotension

Intervention: Epinephrine (Drug); Norepinephrine (Drug); Dobutamine (Drug); Dopexamine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Oxford University Hospitals NHS Trust

Official(s) and/or principal investigator(s):
Stephen R Watt-Smith, FDSRCS, MD, Principal Investigator, Affiliation: Oxford University Hospitals NHS Trust

Summary

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.

Clinical Details

Official title: An Assessment of the Effects of Pressors on Graft Blood Flow After Free Tissue Transfer Surgery: A Randomised Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: Absolute change in transfer function (flap vascular resistance) after pressor infusion.

Secondary outcome:

Relative change in transfer function after pressor infusion compared with "normal" tissue.

Change in flap flow after pressor infusion

Differences in frequency spectrum of skin blood flow between flaps and "normal" tissue before and after pressor infusion.

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

Minimum age: 17 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

Starting date: October 2008
Last updated: August 15, 2011

Page last updated: August 23, 2015

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