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NCT Number: NCT01418118

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

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.

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Key information

Conditions

Oral Cancer Cardiovascular Diseases Free Flap Head and Neck Cancer Head and Neck Neoplasms Hypotension Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Stomatognathic Diseases Vascular Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epinephrine

Drug

0.2mcg/kg/min maximum infusion; to increase mean arterial pressure by 30mmHg

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

Primary outcomes

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

    Time frame: Post infusion (at 4 hours)

Secondary outcomes

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

    Time frame: Post infusion (at 4 hours)

  2. Change in flap flow after pressor infusion

    Time frame: Post infusion (at 4 hours)

  3. 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)

Sponsors and collaborators

Lead sponsor

Oxford University Hospitals NHS Trust

Other

Registry information

Official study title

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

Acronym: Free4Flow

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 16, 2011
Registry last updated
Aug 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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