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NCT Number: NCT06681662

Ephedrine for Reducing Onset Time of Rocurinium in Elderly Patients

The aim of this study is to determine the onset time of rocuronium after administration of ephedrine 0.15 mg/kg in patients with age ≥ 80 years. The hypothesis of this study is that ephedrine 0.15 mg/kg provides a shorter onset time compared to placebo (saline).

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Key information

Age range

80 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anaesthesiology, Pain and Respiratory Support, Rigshospitalet Glostrup, Copenhagen, Denmark

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About this study

Numbers of elderly patients requiring anesthesia and surgery are increasing, and as a group, elderly patients are at high risk of postoperative complications. Aging leads to a progressive impairment of organ function and a decline in physiologic reserve and in the elderly patient population, pharmacodynamics and pharmacokinetics of medications administered during anesthesia may be influenced by the age-related reduction in cardiac output, liver function and renal function. Also, the body composition changes with age and elderly have lower total body water and an increase in body fat.

Neuromuscular blocking agents (NMBAs) are administered during anesthesia to facilitate tracheal intubation. However, in elderly patients onset time of standard doses of NMBAs are prolonged, and for 0.6 mg/kg of rocuronium it is prolonged by 50% when comparing elderly with younger adults (median 135 seconds vs 90 seconds). A prolonged onset time of rocuronium may result in prolonged time to tracheal intubation which aims to secure the patients airway and breathing during anesthesia and thereby prevents pulmonary aspiration and hypoxia. It is therefore relevant to investigate measures to reduce onset time of rocuronium in the elderly.

Ephedrine administered in younger adults undergoing general anesthesia has reduced the onset time of rocuronium 0.6 mg/kg. The mechanism behind this is speculated to be an increase in cardiac output.

It is possible to detect onset time of NMBAs with objective neuromuscular monitoring perioperatively by train-of-four (TOF) stimulation at the ulnar nerve. The effect of ephedrine on onset time of rocuronium has not been assessed in elderly patients above 80 years of age.

The possible benefit of this trial is to investigate whether ephedrine 0.15 mg/kg reduces onset time of rocuronium 0.6 mg/kg in the elderly. This may result in a shorter time to tracheal intubation and also establish better intubating conditions. The results may help to detect the optimal method for administering rocuronium to facilitate tracheal intubation in elderly patients.

The investigators hypothesize that ephedrine 0.15 mg/kg will provide a shorter onset time of rocuronium compared to placebo (saline).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 80
  • Scheduled for elective operations under general anesthesia with intubation
  • American Society of Anesthesiologists physical status classification (ASA) I to III
  • Informed consent
  • Read and understand Danish

Exclusion criteria

  • 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 arrythmia (atrial fibrillation, supraventricular or ventricular)

Treatment and study plan

Ephedrine Hydrochloride 30 mg/ml

Drug

0.15 mg/kg during induction.

Saline (NaCl 0,9 %) (placebo)

Drug

1 ml during induction.

Primary outcomes

  1. Onset time of rocuronium 0.6 mg/kg defined as the time from administration of rocuronium until TOF count of 0.

    Time frame: Within 1 hour

    Onset time is determined by an investigator using a stop-watch.

Secondary outcomes

  1. Intubating conditions assessed by The Intubation Difficulty Scale (IDS)

    Time frame: Within 1 hour

    Tracheal intubation will be performed when TOF count is zero. The anesthesiologist or nurse anesthetist will be interviewed after intubation by the investigator, who will note a score for each variable and the initials of the operator in the CRF. The intubating conditions will be classified with "Degree of Difficulty" according to the IDS scale, where an IDS score of 0 translates to "Easy", a score of 0 < IDS ≤ 5 translates to "Slight Difficulty" and 5 < IDS translates to "Moderate to Major Difficulty". Impossible intubation is defined by infinity (IDS = ∞ ).

  2. Intubating conditions assessed by Fuchs-Buder scale

    Time frame: Within 1 hour

    Tracheal intubation will be performed when TOF count is zero. The anesthesiologist or nurse anesthetist will be interviewed after intubation by the investigator, who will note a score for each variable and the initials of the operator in the CRF. All variables will be assessed as either excellent, good or poor. The intubating conditions will be classified as excellent if all qualities are excellent, good if all qualities are either excellent or good and poor if the presence of a single quality listed as poor.

  3. Occurrence of new cardiac arrythmia during induction of anaesthesia (<15 minutes after administration of ephedrine or saline)

    Time frame: Within 15 minutes

  4. Change in mean arterial blood pressure from before induction to immediately after intubation

    Time frame: Within 1 hour

  5. Time to TOF 0.9

    Time frame: Within 4 hours

Other outcomes

  1. Occurrence of hoarseness and sore throat 24 and 72 hours postoperatively

    Time frame: Within 72 hours

    After 24 hours patients are asked about hoarseness and sore throat. The patients who experience either or both will be called 3 days postoperatively again. These two variables are assessed using a numeric ranking scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Matias Vested, MD, PhD

CONTACT

[email protected]

+45 35 45 75 47

Sponsors and collaborators

Lead sponsor

Matias Vested

Other

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 8, 2024
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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