Ephedrine for Reducing Onset Time of Rocurinium in Elderly Patients

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age80+
SponsorMatias Vested

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 80

Scheduled for elective operations under general anesthesia with intubation

American Society of Anesthesiologists physical status classification (ASA) I to III

Informed consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ephedrine Hydrochloride 30 mg/ml

    Drug

    0.15 mg/kg during induction.

  • Saline (NaCl 0,9 %) (placebo)

    Drug

    1 ml during induction.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Ephedrine groupActive comparator 1 intervention
Group B: Saline groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
Within 1 hour

Secondary outcomes

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 = ∞ ).

Time frame
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.

Time frame
Within 1 hour
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

Other outcomes

1

Occurrence of hoarseness and sore throat 24 and 72 hours postoperatively

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.

Time frame
Within 72 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Matias Vested

Lead sponsor

Rigshospitalet, Denmark

Sponsor institution