Back to resultsThe Effect of Norepinephrine and Dopamine on Radial Forearm Free Flap Tissue Oxygen Pressure and Microdialysate Metabolite Measurements
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Dopamine
Norepinephrine
no medication
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer
Eligibility 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
Sites / Locations
- Tampere University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
dopamine group
norepinephrine group
control group
Arm Description
vasopressor dosage individually titred according to the mean arterial pressure
vasopressor dosage individually titred according to the mean arterial pressure
no medication
Outcomes
Primary Outcome Measures
Evidence of clinically definite ischemia in a flap confirmed by changes in tissue oxygen pressure level and microdialysates metabolites
Secondary Outcome Measures
Full Information
NCT ID
NCT02241083
First Posted
September 12, 2014
Last Updated
September 15, 2014
Sponsor
Tampere University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02241083
Brief Title
The Effect of Norepinephrine and Dopamine on Radial Forearm Free Flap Tissue Oxygen Pressure and Microdialysate Metabolite Measurements
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dopamine group
Arm Type
Active Comparator
Arm Description
vasopressor dosage individually titred according to the mean arterial pressure
Arm Title
norepinephrine group
Arm Type
Active Comparator
Arm Description
vasopressor dosage individually titred according to the mean arterial pressure
Arm Title
control group
Arm Type
Active Comparator
Arm Description
no medication
Intervention Type
Drug
Intervention Name(s)
Dopamine
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Intervention Type
Other
Intervention Name(s)
no medication
Primary Outcome Measure Information:
Title
Evidence of clinically definite ischemia in a flap confirmed by changes in tissue oxygen pressure level and microdialysates metabolites
Time Frame
72 hours
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
State/Province
P.O. Box 2000
ZIP/Postal Code
33521
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
The Effect of Norepinephrine and Dopamine on Radial Forearm Free Flap Tissue Oxygen Pressure and Microdialysate Metabolite Measurements
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