NCT01418118

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Oxford University Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Epinephrine	0.2mcg/kg/min maximum infusion; to increase mean arterial pressure by 30mmHg
DRUG	Norepinephrine	Maximum infusion of 0.2mcg/kg/min, to increase mean arterial pressure by 30mmHg
DRUG	Dobutamine	Maximum infusion rate of 8mcg/kg/min to increase mean arterial pressure by 30mmHg
DRUG	Dopexamine	Maximum infusion rate of 5mcg/kg/min to increase mean arterial pressure by 30mmHg

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2011-08-16
• Last updated: 2011-08-16

Locations

1 site across 1 country: United Kingdom