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

Phase 4
17 Years
Not Enrolling
Oral Cancer, Head and Neck Cancer, Free Flap, Hypotension

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Trial Information

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

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Post infusion (at 4 hours)

Safety Issue:


Principal Investigator

Stephen R Watt-Smith, FDSRCS, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oxford University Hospitals NHS Trust


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

2008-000073-37 5579



Start Date:

October 2008

Completion Date:

February 2010

Related Keywords:

  • Oral Cancer
  • Head and Neck Cancer
  • Free Flap
  • Hypotension
  • noradrenaline
  • norepinephrine
  • epinephrine
  • adrenaline
  • dobutamine
  • dopexamine
  • inotrope
  • pressor
  • sympathomimetic
  • free flap
  • transplantation
  • free tissue transfer
  • microsurgery
  • survival
  • Head and Neck Neoplasms
  • Hypotension
  • Mouth Neoplasms