Actively Recruiting
A Blinded Randomized Study of Ephedrine 0.15 mg/kg for Reducing Onset Time of Rocuronium 0.6 mg/kg in Elderly Patients (≥ 80 Years)
Led by Matias Vested · Updated on 2025-01-17
80
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to determine how quickly rocuronium begins to work after giving ephedrine 0.15 mg/kg in patients aged 80 years and older. Elderly patients often face higher risks during anesthesia due to age-related changes in organ function, body composition, and drug processing. The study tests whether ephedrine can shorten the time it takes for rocuronium to take effect compared to a placebo. This is important because rocuronium helps with tracheal intubation during surgery, and a faster onset could improve intubation safety and conditions in older adults. Participants will receive either ephedrine at a dose based on ideal or actual body weight or a saline placebo during anesthesia induction. The rocuronium dose is 0.6 mg/kg for all. The study is randomized and triple-blinded, with two groups comparing the effects of ephedrine versus saline. The timing of rocuronium onset is monitored using train-of-four stimulation at the ulnar nerve. Additional measures include intubation difficulty and cardiac responses during anesthesia induction. Participants will be monitored closely during and after anesthesia induction. Researchers will assess the time from rocuronium administration to neuromuscular blockade, intubation conditions using specific scales, and any cardiac arrhythmias occurring shortly after drug administration. Blood pressure changes and recovery times are also recorded. The primary outcome is measured within one hour, and other assessments occur up to four hours after treatment. The study provides detailed evaluation to understand ephedrine's impact on rocuronium onset in the elderly.
CONDITIONS
Brief 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 physical status classification (ASA) I to III
- Able to provide 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
- Indication for rapid sequence induction
- Daily use of beta-blocking agents
- Known cardiac arrhythmia such as atrial fibrillation, supraventricular or ventricular arrhythmias
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 hour
Participants receive an injection of ephedrine 0.15 mg/kg or saline placebo during anesthesia induction to study its effect on the onset time of rocuronium 0.6 mg/kg for tracheal intubation.
1 treatment visit during anesthesia induction
Duration - Up to 4 hours
Participants are monitored for cardiac arrhythmias and intubation conditions shortly after treatment and for neuromuscular recovery up to 4 hours post-treatment.
Continuous monitoring during and after treatment visit
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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