Matias Vested
Matias Vested
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).
Neuromuscular Blockade
Ephedrine Hydrochloride 30 mg/ml
Saline (NaCl 0,9 %) (placebo)
PHASE4
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).
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 80 participants |
| Masking : | TRIPLE |
| Masking Description : | * The surgeon will be blinded to treatment group allocation during the induction. * The anesthesia personnel will be blinded to treatment group allocation during induction and intubation, but after gathering the data, they will be unblinded. * The investigator controlling the nerve stimulator will be blinded throughout the whole procedure. * Surgical personnel will be blinded to treatment group allocation during induction. |
| Primary Purpose : | TREATMENT |
| 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) |
| Actual Study Start Date : | 2024-12 |
| Estimated Primary Completion Date : | 2025-09 |
| Estimated Study Completion Date : | 2025-12 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 80 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
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Department of Anaesthesiology, Pain and Respiratory Support, Rigshospitalet Glostrup
Copenhagen, Denmark, 2100
Not yet recruiting
Department of Anesthesia, Centre of Head and Orthopedics, 6013 Rigshospitalet
Copenhagen, Denmark, 2100