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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01418118
Acronym
Free4Flow
Enrollment
25
Registered
2011-08-16
Start date
2008-10-31
Completion date
2010-02-28
Last updated
2011-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Free Flap, Head and Neck Cancer, Hypotension, Oral Cancer

Keywords

noradrenaline, norepinephrine, epinephrine, adrenaline, dobutamine, dopexamine, inotrope, pressor, sympathomimetic, free flap, transplantation, free tissue transfer, microsurgery, survival

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.

Interventions

DRUGEpinephrine

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

DRUGNorepinephrine

Maximum infusion of 0.2mcg/kg/min, to increase mean arterial pressure by 30mmHg

DRUGDobutamine

Maximum infusion rate of 8mcg/kg/min to increase mean arterial pressure by 30mmHg

DRUGDopexamine

Maximum infusion rate of 5mcg/kg/min to increase mean arterial pressure by 30mmHg

Sponsors

Oxford University Hospitals NHS Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Absolute change in transfer function (flap vascular resistance) after pressor infusion.Post infusion (at 4 hours)

Secondary

MeasureTime frame
Relative change in transfer function after pressor infusion compared with normal tissue.Post infusion (at 4 hours)
Change in flap flow after pressor infusionPost infusion (at 4 hours)
Differences in frequency spectrum of skin blood flow between flaps and normal tissue before and after pressor infusion.Post infusion (at 4 hours)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026