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

Phase 4

Completed

• Conditions: Oral Cancer; Head and Neck Cancer; Free Flap; Hypotension
• Interventions: Drug: Epinephrine; Drug: Norepinephrine; Drug: Dobutamine; Drug: Dopexamine

• Registration Number: NCT01418118
• Lead Sponsor: Oxford University Hospitals NHS Trust

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 Timeline

• Study Start: 2008-10
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2011-08
• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2011-08-15
• Last Update Submitted: 2011-08-15
• Study First Posted: 2011-08-16
• Last Update Posted: 2011-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Patients undergoing free tissue transfer surgery at the John Radcliffe Hospital wih planned post-operative admission to the intensive care unit.

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Exclusion Criteria

• Pregnancy
• Weight >100kg
• Contraindications to pressor infusions
• Overnight ventilation not indicated

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pressors	Norepinephrine	Epinephrine, Norepinephrine, Dobutamine, Dopexamine
Pressors	Epinephrine	Epinephrine, Norepinephrine, Dobutamine, Dopexamine
Pressors	Dobutamine	Epinephrine, Norepinephrine, Dobutamine, Dopexamine
Pressors	Dopexamine	Epinephrine, Norepinephrine, Dobutamine, Dopexamine

Primary Outcome Measures

Name	Time	Method
Absolute change in transfer function (flap vascular resistance) after pressor infusion.	Post infusion (at 4 hours)

Secondary Outcome Measures

Name	Time	Method
Relative change in transfer function after pressor infusion compared with "normal" tissue.	Post infusion (at 4 hours)
Change in flap flow after pressor infusion	Post 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)

Trial Locations

Locations (1)

John Radcliffe Hospital; 🇬🇧 Oxford, Oxfordshire, United Kingdom