Intraoperative Bradycardia
Conditions
Brief summary
The RAPID trial is a randomized, single-center trial investigating whether giving atropine at heart rates below 60 beats per minute versus giving atropine only at heart rates below 30 beats per minute reduces the amount of norepinephrine needed to keep MAP above 65 mmHg in non-cardiac surgery patients with intraoperative bradycardia.
Interventions
DRUGGiving atropine at heart rates below 60 beats per minute
In patients assigned to the atropine therapy at heart rates below 60 beats per minute, atropine will be given at a dose of 0.5 mg when heart rate is below 60 beats per minute for one continuous minute. A second and third atropine dose of 0.5 mg will be given if heart rate remains or again drops below 60 beats per minute for one continuous minute. Patients will not be given more than 1.5 mg atropine.
DRUGGiving atropine at heart rates below 30 beats per minute
In patients assigned to atropine therapy at heart rates below 30 beats per minute, atropine will be given at a dose of 0.5 mg when heart rate is below 30 beats per minute for one continuous minute. A second and third atropine dose of 0.5 mg will be given if heart rate remains or again drops below 30 beats per minute for one continuous minute. Patients will not be given more than 1.5 mg atropine.
Sponsors
University of Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Consenting patients ≥50 years scheduled for elective non-cardiac surgery with general anesthesia that is expected to last ≥60 minutes with at least two of the following risk criteria for developing acute kidney injury: * Age ≥65 years * American Society of Anesthesiologists physical status III or IV * Chronic arterial hypertension * Diabetes mellitus requiring medication * Intraabdominal surgery * Preoperative renal insufficiency (serum creatinine ≥1.2 mg/dL)
Exclusion criteria
Patients with the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average norepinephrine infusion rate | Perioperative | Average norepinephrine infusion rate in μg per kg actual body weight per minute (μg kg-1 min-1) needed to keep MAP above 65 mmHg from anesthetic induction until the end of surgery (continuous outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-weighted average MAP <65 mmHg | Perioperative | From anesthetic induction until the end of surgery |
| Time-weighted average heart rate <60 bpm | Perioperative | From anesthetic induction until the end of surgery |
| Time-weighted average MAP >110 mmHg | Perioperative | From anesthetic induction until the end of surgery |
| Time-weighted average heart rate >100 bpm | Perioperative | From anesthetic induction until the end of surgery |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORAlina Bergholz, MD
University Medical Centre Hamburg-Eppendorf
Outcome results
None listed