Clinical trial NCT01418118: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oral Cancer
Head and Neck Cancer
Free Flap
Hypotension
Keywords: noradrenaline
norepinephrine
epinephrine
adrenaline
dobutamine
dopexamine
inotrope
pressor
sympathomimetic
free flap
transplantation
free tissue transfer
microsurgery
survival
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2011-08-16
Enrollment: 25
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Absolute change in transfer function (flap vascular resistance) after pressor infusion.
timeFrame: Post infusion (at 4 hours)
Secondary outcomes:
measure: Relative change in transfer function after pressor infusion compared with "normal" tissue.
timeFrame: Post infusion (at 4 hours)
measure: Change in flap flow after pressor infusion
timeFrame: Post infusion (at 4 hours)
measure: Differences in frequency spectrum of skin blood flow between flaps and "normal" tissue before and after pressor infusion.
timeFrame: Post infusion (at 4 hours)
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
state: Oxfordshire
Study officials:
affiliation: Oxford University Hospitals NHS Trust
name: Stephen R Watt-Smith, FDSRCS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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):564-570. doi: 10.1097/PRS.0b013e31825dbf73.