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

Tampere University Hospital

Status and phase: Completed; Phase 4

Conditions: Head and Neck Cancer

Treatments: Other: no medication; Drug: Norepinephrine; Drug: Dopamine

Study type: Interventional

Funder types: Other

Identifiers

NCT02241083

R05114

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

dopamine group

Active Comparator group

Description:

vasopressor dosage individually titred according to the mean arterial pressure

Treatment:

Drug: Dopamine

norepinephrine group

Active Comparator group

Description:

vasopressor dosage individually titred according to the mean arterial pressure

Treatment:

Drug: Norepinephrine

control group

Active Comparator group

Description:

no medication

Treatment:

Other: no medication