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

NCT06922097 | Completed

• 1 other identifier: 2025-101426-BO-ff
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraoperative Bradycardia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Time-weighted average MAP <65 mmHg

  Perioperative

• Time-weighted average heart rate <60 bpm

  Perioperative

• Time-weighted average MAP >110 mmHg

  Perioperative

• Time-weighted average heart rate >100 bpm

  Perioperative

Other Outcomes (5)

• Incidence of acute kidney injury

  Within the first 3 postoperative days

• Incidence of delirium

  Within the first 3 postoperative days

• Incidence of urinary retention

  Within the first 3 postoperative days

Study Arms (2)

Giving atropine at heart rates below 60 beats per minute

EXPERIMENTAL

Drug: Giving atropine at heart rates below 60 beats per minute

Giving atropine at heart rates below 30 beats per minute

ACTIVE COMPARATOR

Drug: Giving atropine at heart rates below 30 beats per minute

Interventions

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 60 beats per minute

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.

Giving atropine at heart rates below 30 beats per minute

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• University of Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Study Officials

• Alina Bergholz, MD

  University Medical Centre Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: April 10, 2025
• Study Start: April 7, 2025
• Primary Completion: November 11, 2025
• Study Completion: December 16, 2025
• Last Updated: April 29, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)