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The Effect of Norepinephrine and Dopamine on Radial Forearm Free Flap Tissue Oxygen Pressure and Microdialysate Metabolite Measurements

Information source: Tampere University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Head and Neck Cancer

Intervention: Dopamine (Drug); Norepinephrine (Drug); no medication (Other)

Phase: Phase 4

Status: Completed

Sponsored by: Tampere University Hospital

Summary

Vasopressors may be needed after head and neck microvascular reconstructions to maintain sufficient mean arterial pressure. This is crucial for the flap survival. The study hypothesis is that norepinephrine and dopamine used as vasopressors do not affect flap tissue oxygen level and microdialysate metabolites.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Evidence of clinically definite ischemia in a flap confirmed by changes in tissue oxygen pressure level and microdialysates metabolites

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- head and neck cancer patients having tumor ablation surgery and reconstruction with

microvascular radial forearm flap Exclusion Criteria:

- Patients having contraindications for the operation.

- Patient refusal to participate in the study

Locations and Contacts

Tampere University Hospital, Tampere, P.O. Box 2000 33521, Finland
Additional Information

Starting date: June 2006
Last updated: September 15, 2014

Page last updated: August 23, 2015

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