Skip to main content
OpenTrials
Completed

NCT Number: NCT06922097

Treating Intraoperative Bradycardia in Non-cardiac Surgery Patients With Atropine at Heart Rates Below 60 Versus 30 Beats Per Minute and Norepinephrine Requirements

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intraoperative Bradycardia

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Average norepinephrine infusion rate

    Time frame: 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 outcomes

  1. Time-weighted average MAP <65 mmHg

    Time frame: Perioperative

    From anesthetic induction until the end of surgery

  2. Time-weighted average heart rate <60 bpm

    Time frame: Perioperative

    From anesthetic induction until the end of surgery

  3. Time-weighted average MAP >110 mmHg

    Time frame: Perioperative

    From anesthetic induction until the end of surgery

  4. Time-weighted average heart rate >100 bpm

    Time frame: Perioperative

    From anesthetic induction until the end of surgery

Other outcomes

  1. Incidence of acute kidney injury

    Time frame: Within the first 3 postoperative days

    Acute kidney injury (binary outcome) will be defined as an increase in postoperative creatinine of ≥50 % from baseline.

  2. Incidence of delirium

    Time frame: Within the first 3 postoperative days

    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.

  3. Incidence of urinary retention

    Time frame: Within the first 3 postoperative days

    Urinary retention (binary outcome) will be assessed by reviewing the diagnoses documented in the patients' medical records within the first 3 postoperative days.

  4. Incidence of central anticholinergic syndrome

    Time frame: Within the first 3 postoperative days

    Central anticholinergic syndrome (binary outcome) will be assessed by reviewing the diagnoses documented in the patients' medical records within the first 3 postoperative days.

  5. Incidence of acute angle-closure glaucoma

    Time frame: Within the first 3 postoperative days

    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.

Sponsors and collaborators

Lead sponsor

University of Hamburg-Eppendorf

Other

Registry information

Official study title

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

Acronym: RAPID

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 10, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.