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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Giving atropine at heart rates below 60 beats per minute | Experimental |
| |
| Giving atropine at heart rates below 30 beats per minute | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Giving atropine at heart rates below 60 beats per minute | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Average norepinephrine infusion rate | 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) | Perioperative |
| Measure | Description | Time Frame |
|---|---|---|
| Time-weighted average MAP <65 mmHg | From anesthetic induction until the end of surgery | Perioperative |
| Time-weighted average heart rate <60 bpm | From anesthetic induction until the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute kidney injury | Acute kidney injury (binary outcome) will be defined as an increase in postoperative creatinine of ≥50 % from baseline. | Within the first 3 postoperative days |
| Incidence of delirium |
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:
Exclusion Criteria:
Patients with the following exclusion criteria: contraindication for atropine administration (e.g., myasthenia gravis, high-grade aortic stenosis, high-grade coronary artery disease, glaucoma, paralytic ileus, prostatic hypertrophy); renal replacement therapy within the previous 3 months; chronic kidney disease with an estimated glomerular filtration rate <20 mL/min/1.73 m2; pregnancy.
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| Name | Affiliation | Role |
|---|---|---|
| Alina Bergholz, MD | University Medical Centre Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Hamburg | 20246 | Germany |
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|
| Giving atropine at heart rates below 30 beats per minute | Drug | 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. |
|
| Perioperative |
| Time-weighted average MAP >110 mmHg | From anesthetic induction until the end of surgery | Perioperative |
| Time-weighted average heart rate >100 bpm | From anesthetic induction until the end of surgery | Perioperative |
Delirium (binary outcome) will be assessed twice daily within the first three postoperative days using the 3-Minute Diagnostic Confusion Assessment Method for patients on normal wards and the Confusion Assessment Method for Intensive Care Unit for patients in intensive care units.
| Within the first 3 postoperative days |
| Incidence of urinary retention | Urinary retention (binary outcome) will be assessed by reviewing the diagnoses documented in the patients' medical records within the first 3 postoperative days. | Within the first 3 postoperative days |
| Incidence of central anticholinergic syndrome | Central anticholinergic syndrome (binary outcome) will be assessed by reviewing the diagnoses documented in the patients' medical records within the first 3 postoperative days. | Within the first 3 postoperative days |
| Incidence of acute angle-closure glaucoma | Acute angle-closure glaucoma (binary outcome) will be assessed by reviewing the diagnoses documented in the patients' medical records within the first 3 postoperative days. | Within the first 3 postoperative days |