Patients in need of free flap facial reconstructive surgery
Conditions
Interventions
Trade Name: Dopacard
Product Name: Dopexamine
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: DOPEXAMINE HYDROCHLORIDE
CAS Number: 86484915
Concentration unit: % (W/V) percent weight/v
Sponsors
Oxford Radcliffe Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion are those undergoing oral reconstruction using free flaps at the John Radcliffe Hospital in Oxford and expected to be admitted to the Adult Intensive Care Unit post-operatively. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from the trial if they: • are having repeat surgery, • refuse consent, • are contraindicated for pressor infusions, • are not planned to be ventilated overnight - are prisoners - are unable to give consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Absolute change in transfer function (flap vascular resistance) after pressor infusion.;Secondary Objective: • Relative change in transfer function after pressor infusion compared with “normal” tissue. • Change in flap flow after pressor infusion. • Differences in frequency spectrum of skin blood flow between flaps and “normal” tissue before and after pressor infusion. ;Primary end point(s): To identify the optimal pharmacological agent for blood pressure maintenance after free tissue transfer surgery by investigating in the allocated random order, which of 4 commonly used and available licensed pressors achieves the best free flap blood flow as well as increasing blood pressure. | — |
Countries
United Kingdom
Outcome results
None listed