Actively Recruiting

Phase 4
Age: 80Years +
All Genders
ID06681662

A Randomized Study of Ephedrine 0.15 mg/kg to Reduce Onset Time of Rocuronium 0.6 mg/kg in Patients Aged 80 and Older

Led by Matias Vested · Updated on 2025-01-17

80

Participants Needed

2

Research Sites

46 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to find out how quickly the drug rocuronium works to relax muscles in patients aged 80 and older. Older adults often face higher risks during surgery due to changes in their heart, liver, kidneys, and body composition. Because rocuronium usually takes longer to work in elderly patients, this study tests whether giving a dose of ephedrine before rocuronium can speed up its effect and help with safer intubation during anesthesia. Participants will receive either ephedrine at a dose of 0.15 mg/kg or a placebo (saline) during anesthesia induction. After this, they receive rocuronium at 0.6 mg/kg to relax muscles for intubation. Researchers will measure the time it takes from giving rocuronium until muscle relaxation is complete using a device that monitors nerve responses. The study is blinded and randomized, meaning neither the patients nor the researchers know which treatment is given. Throughout the study, participants will be monitored closely with neuromuscular tests during surgery to track how fast rocuronium works. The main outcome is the onset time of rocuronium within one hour. The study includes patients undergoing planned surgeries who can provide informed consent and understand Danish. Safety and treatment effects will be observed during the anesthesia period.

CONDITIONS

Official Title

Ephedrine for Reducing Onset Time of Rocurinium in Elderly Patients

Who Can Participate

Age: 80Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 80 years or older
  • Scheduled for elective operations under general anesthesia with intubation
  • American Society of Anesthesiologists (ASA) physical status classification I to III
  • Able to give informed consent
  • Able to read and understand Danish
Not Eligible

You will not qualify if you...

  • Known allergy to rocuronium or ephedrine
  • Neuromuscular disease that may interfere with neuromuscular data
  • Need for rapid sequence induction
  • Daily use of beta-blocking agents
  • Known cardiac arrhythmia such as atrial fibrillation, supraventricular, or ventricular arrhythmia

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Department of Anaesthesiology, Pain and Respiratory Support, Rigshospitalet Glostrup

Copenhagen, Denmark, 2100

Actively Recruiting

2

Department of Anesthesia, Centre of Head and Orthopedics, 6013 Rigshospitalet

Copenhagen, Denmark, 2100

Actively Recruiting

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Research Team

M

Matias Vested, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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