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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Ephedrine Hydrochloride 30 mg/ml
Drug0.15 mg/kg during induction.
Saline (NaCl 0,9 %) (placebo)
Drug1 ml during induction.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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 = ∞ ).
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.
Occurrence of new cardiac arrythmia during induction of anaesthesia (<15 minutes after administration of ephedrine or saline)
Change in mean arterial blood pressure from before induction to immediately after intubation
Other outcomes
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.
Sponsors and contacts
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Matias Vested
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution