Head and Neck Cancer Clinical Trial
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Finland | Tampere University Hospital | Tampere | P.O. Box 2000 |
Lead Sponsor | Collaborator |
---|---|
Tampere University Hospital |
Finland,
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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