Using atropine to treat slow heart rates during non-cardiac surgeries
Treating Intraoperative Bradycardia in Non-cardiac Surgery Patients With Atropine at Heart Rates Below 60 Versus 30 Beats Per Minute and Norepinephrine Requirements: the Randomized RAPID Trial
This study is testing if giving atropine to older patients with slow heart rates during non-heart surgeries can help them avoid needing extra medication to keep their blood pressure stable.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 186 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of Hamburg-Eppendorf Academic / other |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT06922097 on ClinicalTrials.gov |
What this trial studies
The RAPID trial is a randomized, single-center investigation that evaluates the effectiveness of administering atropine to patients with intraoperative bradycardia at heart rates below 60 beats per minute compared to those receiving it only at rates below 30 beats per minute. The primary goal is to determine if this approach can reduce the need for norepinephrine to maintain mean arterial pressure above 65 mmHg in non-cardiac surgery patients. The study focuses on patients aged 50 and older who are at risk for acute kidney injury during elective surgeries requiring general anesthesia lasting at least 60 minutes.
Who should consider this trial
Good fit: Ideal candidates are patients aged 50 and older scheduled for elective non-cardiac surgery with specific risk factors for acute kidney injury.
Not a fit: Patients with contraindications to atropine or those with severe chronic kidney disease or requiring renal replacement therapy are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of intraoperative bradycardia, potentially reducing the need for norepinephrine and enhancing patient outcomes during surgery.
How similar studies have performed: While there have been studies on atropine use in various settings, this specific approach in non-cardiac surgery patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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.
Where this trial is running
Hamburg
- University Medical Center Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
Study contacts
- Principal investigator: Alina Bergholz, MD — University Medical Centre Hamburg-Eppendorf
- Study coordinator: Alina Bergholz MD
- Email: a.bergholz@uke.de
- Phone: +4940 7410 0
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.