Perioperative esmolol infusion titrated for heart rate control as an add-on to standard therapy including a long acting oral beta-blocker will improve heart rate control and decrease perioperative myocardial ischemia, without an increase in…
ID
Bron
Verkorte titel
Aandoening
atherosclerosis, vascular surgery, esmolol, cardiac complications
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Time with a heart rate outside the 60-80 BPM target window during the study drug infusion period.
Achtergrond van het onderzoek
This study will provide data on the efficacy of esmolol titration in
chronic beta-blocker users for tight heart rate control and reduction of
ischemia in patients undergoing vascular surgery as well as data on safety
parameters.
Doel van het onderzoek
Perioperative esmolol infusion titrated for heart rate control as an add-on to standard therapy including a long acting oral beta-blocker will improve heart rate control and decrease perioperative myocardial ischemia, without an increase in complications as bradycardia, hypotension, heart failure and stroke.
Onderzoeksopzet
1. During study drug infusion;
2. Follow-up 30 days.
Onderzoeksproduct en/of interventie
Infusion of esmolol or placebo, initiated during surgery for 24 hours, titrated for a target heart rate of 60-80 BPM, as an add-on to standard therapy including long acting, chronic, oral beta-blocker therapy.
Algemeen / deelnemers
Department of Anesthesiology
D. Poldermans
Dr. Molewaterplein 40
Rotterdam 3015 GD
The Netherlands
+31 10 4634613
d.poldermans@erasmusmc.nl
Wetenschappers
Department of Anesthesiology
D. Poldermans
Dr. Molewaterplein 40
Rotterdam 3015 GD
The Netherlands
+31 10 4634613
d.poldermans@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Adult patient undergoing elective major vascular surgery.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Bleeding;
2. Unstable cardiac conditions;
3. Contraindications for esmolol use;
4. Failure to provide informed consent;
5. Cancer with life expectancy <6 months;
6. Alcohol abuse;
7. Failure to monitor heart rate and ischemia by continuous 12-lead ECG recording.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2498 |
| NTR-old | NTR2615 |
| CCMO | NL33197.078.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON34500 |