The Effect of Norepinephrine and Dopamine on Radial Forearm Free Flap Tissue Oxygen Pressure and Microdialysate Metabolite Measurements
Sponsor
Tampere University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02241083
Collaborator
(none)
25
1
3
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date
:
Jun 1, 2006
Actual Primary Completion Date
:
May 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: dopamine group vasopressor dosage individually titred according to the mean arterial pressure |
Drug: Dopamine
|
| Active Comparator: norepinephrine group vasopressor dosage individually titred according to the mean arterial pressure |
Drug: Norepinephrine
|
| Active Comparator: control group no medication |
Other: no medication
|
Outcome Measures
Primary Outcome Measures
- Evidence of clinically definite ischemia in a flap confirmed by changes in tissue oxygen pressure level and microdialysates metabolites [72 hours]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tampere University Hospital | Tampere | P.O. Box 2000 | Finland | 33521 |
Sponsors and Collaborators
- Tampere University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Minna Kääriäinen,
MD, PhD, Senior Consultant, Associate Chief,
Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT02241083
Other Study ID Numbers:
- R05114
First Posted:
Sep 16, 2014
Last Update Posted:
Sep 16, 2014
Last Verified:
Sep 1, 2014