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

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Brief Title

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

Official Title

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

Brief 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.
    

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.
    

Study Phase

Phase 4

Study Type

Interventional


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.

Condition

Oral Cancer

Intervention

Epinephrine

Study Arms / Comparison Groups

 Pressors
Description:  Epinephrine, Norepinephrine, Dobutamine, Dopexamine

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

25

Start Date

October 2008

Completion Date

February 2010

Primary Completion Date

February 2010

Eligibility 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
      

Gender

All

Ages

17 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Stephen R Watt-Smith, FDSRCS, MD, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT01418118

Organization ID

2008-000073-37 5579

Secondary IDs

2008 000073 37


Study Sponsor

Oxford University Hospitals NHS Trust


Study Sponsor

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


Verification Date

August 2011