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

Phase 4

Completed

• Conditions: Head and Neck Cancer
• Interventions: Drug: Norepinephrine; Other: no medication; Drug: Dopamine

• Registration Number: NCT02241083
• Lead Sponsor: Tampere University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2014-05
• Status Verified: 2014-09
• Study First Submitted: 2014-09-12
• Study First Submitted QC: 2014-09-15
• Last Update Submitted: 2014-09-15
• Study First Posted: 2014-09-16
• Last Update Posted: 2014-09-16

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
norepinephrine group	Norepinephrine	vasopressor dosage individually titred according to the mean arterial pressure
control group	no medication	no medication
dopamine group	Dopamine	vasopressor dosage individually titred according to the mean arterial pressure

Primary Outcome Measures

Name	Time	Method
Evidence of clinically definite ischemia in a flap confirmed by changes in tissue oxygen pressure level and microdialysates metabolites	72 hours

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, P.O. Box 2000, Finland