Actively Recruiting

Phase 4
Age: 80Years +
All Genders
ID06681662

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

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 physical status classification (ASA) I to III
  • Able to provide 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
  • 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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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

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