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Neuromuscular BlockadePhase 4NCT06681662

Ephedrine for Reducing Onset Time of Rocurinium in Elderly Patients

A Phase 4 study testing Ephedrine Hydrochloride 30 mg/ml in people with Neuromuscular Blockade, run by Matias Vested at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 80 years and older
Conditions the study is for
Neuromuscular Blockade
What is being tested?
Ephedrine Hydrochloride 30 mg/ml
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
2 sitesDenmark
Study dates
13 Jan 2025to 5 Oct 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 80 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Department of Anaesthesiology, Pain and Respiratory Support, Rigshospitalet Glostrup

    Copenhagen, 2100

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

    Copenhagen, 2100

Other trials in Denmark

About this study

Official 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)

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).

Read the detailed description

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).

Being tested
Ephedrine Hydrochloride 30 mg/ml, Saline (NaCl 0,9 %) (placebo)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ephedrine Hydrochloride 30 mg/mlDrug

    0.15 mg/kg during induction.

  • Saline (NaCl 0,9 %) (placebo)Drug

    1 ml during induction.

Study groups in NCT06681662
Study groupRoleWhat they receive
Ephedrine groupActive comparatorEphedrine 0.15 mg/kg. Dose of ephedrine is based on ideal body weight, calculated as height (cm) minus 105 for women and height (cm) minus 100 for men or actual body weight, whichever is lower.
Receives: Drug: Ephedrine Hydrochloride 30 mg/ml
Saline groupPlacebo comparatorSaline 1 ml.
Receives: Drug: Saline (NaCl 0,9 %) (placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Within 1 hour

Secondary outcomes (5)

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

    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 = ∞ ).

    Measured: Within 1 hour

  2. Intubating conditions assessed by Fuchs-Buder scale

    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.

    Measured: Within 1 hour

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

    Measured: Within 15 minutes

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

    Measured: Within 1 hour

  5. Time to TOF 0.9

    Measured: Within 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2024
  2. Study start13 Jan 2025
  3. Primary completion5 Oct 2025
  4. Study completion5 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a randomized study. Patients will be allocated randomly at a ratio of 1:1 to receive either 0.15 mg/kg ephedrine or saline (placebo). Randomization will be done at the day of operation after written informed consent is obtained. An independent investigator will allocate patients by using a computerized random number generator in REDCap. In REDCap patients also receive a number, which pseudo anonymizes data. The study drug is prepared in the medicine room before the operation. This is done under double control by the investigator who also performed the randomization. The study drug, either ephedrine or saline, will be prepared in a 1 mL syringe. The dose will be mixed with saline to a total of 1 mL to secure blinding.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06681662
Sponsor's protocol ID
Ephedrine for rocuronium
Status last verified
Sep 2026
First submitted
5 Nov 2024
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vested M, Hovind MF, Nielsen T, Wadland SS, Jensen MH, Slente AR, Madsen KPD, Skovmand K, Rosa F, Albrechtsen C, Rasmussen LS. Ephedrine for Reducing Onset Time of Rocuronium in Elderly Patients: A Randomised Study. Acta Anaesthesiol Scand. 2026 Nov;70(10):e70344. doi: 10.1111/aas.70344.

    PubMed 42791593

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ephedrine Hydrochloride 30 mg/ml in people with Neuromuscular Blockade, run by Matias Vested at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06681662, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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