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NCT02241083 Clinical Trial

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

Head and Neck Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02241083
Other study ID # R05114
Secondary ID
Status Completed
Phase Phase 4
First received September 12, 2014
Last updated September 15, 2014
Start date June 2006

Study information
Verified date September 2014
Source Tampere University Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: Finnish National Agency for Medicines
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Drug:
• Dopamine

• Norepinephrine

Other:
• no medication

Locations
Country Name City State
Finland Tampere University Hospital Tampere P.O. Box 2000

Sponsors (1)
Lead Sponsor Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evidence of clinically definite ischemia in a flap confirmed by changes in tissue oxygen pressure level and microdialysates metabolites 72 hours Yes
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