Does intravenous infusion of low doses dobutamine solely peroperative or for 18 more hours postoperative in women undergoing a breast reconstruction by menas of a DIEP flap, increase the blood flow in arterioles after dobutamine infusion as compared…
ID
Bron
Aandoening
Dobutamine, microcirculation, DIEP-flap, Laser Doppler
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
increase in blood flow (PU, measured by means of laser doppler)
Achtergrond van het onderzoek
Since dobutamine in low doses exerts both a vasodilatory as an inotropic effect, infusion during free flap surgery is suggested to increase the arterial flow and hence decrease the complication rate. With this trial we want to investigate whether dobutamine infusion increases the flow in free flap surgery, and consequently decreases the complication rate in a double-blind placebo controlled intervention study.
Doel van het onderzoek
Does intravenous infusion of low doses dobutamine solely peroperative or for 18 more hours postoperative in women undergoing a breast reconstruction by menas of a DIEP flap, increase the blood flow in arterioles after dobutamine infusion as compared to placebo (NaCl 0.9% infusion) measured by means of laser doppler
Onderzoeksopzet
- baseline
- peroperative
- postoperative (first day, 2 weeks, 6 weeks and 3 months)
Onderzoeksproduct en/of interventie
- dobutamine peroperative, 18 hours post-operative placebo
- dobutamine peroperative and 18 hours post-operative
- placebo both per- and postoperative
Publiek
dr. H. van der Hoffplein 1
L. Solberg,
Sittard 6162 BG
The Netherlands
06-50829183
solberglaura@gmail.com.
Wetenschappelijk
dr. H. van der Hoffplein 1
L. Solberg,
Sittard 6162 BG
The Netherlands
06-50829183
solberglaura@gmail.com.
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- women
- age between 30 and 65 years old
- breast carcinoma in the history
- mastectomy in the history
- planned secondary reconstruction by means of a DIEP-flap
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- cardiac history (specifically atrial fibrillation and/or cardiac ischemia)
- clotting disorders (deep venous thrombosis or pulmonary embolus in the medical history)
- smoking
- known allergy for dobutamine and/or bisulfite
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4043 |
| NTR-old | NTR4209 |
| CCMO | NL42897.096.13 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON38526 |