Actively Recruiting
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
Eligibility Criteria
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
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
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
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