An observational study in Neuromuscular Blockade, Anesthesia and TOF, sponsored by Hospital do Divino Espírito Santo de Ponta Delgada. Completed at 1 site in Portugal. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-02-21.
Sponsored by Hospital do Divino Espírito Santo de Ponta Delgada · Observational
Many clinicians continue to rely on subjective evaluation in making decisions about the adequacy of neuromuscular function before tracheal extubation rather than using quantitative monitoring. The aim was to compare the sugammadex dose as suggested by senior anaesthesiologists (SSD) based on clinical experience versus the dose determined by quantitative monitoring (QSD) to determine if the subjective dose was appropriate.
Materials and Methods:
After obtaining approval from the Institute Ethics Committee, a prospective 3-month study in patients aged 18-75 years who underwent general anesthesia with rocuronium (initial dose 0.6 mg/kg) NMB and subsequent reversal with sugammadex, was carried out. American Society of Anesthesiologists (ASA ) physical status V, emergency surgery, patients with hypersensitivity history to rocuronium or sugammadex, severe renal impairment/dialysis, neuromuscular diseases, severe hepatic disease, pre-existing coagulopathies and pregnancy were excluded. Monitoring included ASA standard monitoring, bispectral index and NMB monitoring using TOFscan® monitor. The senior anaesthesiologist was blinded to the TOFscan®, which was only available to the author.
At the time of pharmacologic reversal of NMB, both the sugammadex dose proposed by the anaesthesiologist (SSD) and the dose suggested by TOFscan® (QSD) according to the Portuguese recommendations for the management of NMB were recorded. Afterwards the QSD was administered to overcome ethical issues. When train-of-four (TOF) count was 0, the author performed the post tetanic count (PTC) stimulus to determine the recommended dose. The SSD was considered appropriate if it was within 10% of the QSD for the depth of NMB. All patients were extubated with a TOF ratio > 0.9 (TOFr) and both the rocuronium and sugammadex dose were calculated based on the real patient weight. Data regarding anaesthesia, duration of anaesthesia and dosing pattern of rocuronium were also noted. The results were analysed descriptively.
99 studies on the registry are indexed under Delayed Emergence from Anesthesia; 15 are open to participants now.
This study's enrollment of 66 is below the median of 120 across 39 observational studies indexed under Delayed Emergence from Anesthesia.
Browse Delayed Emergence from Anesthesia studies →Hospital do Divino Espírito Santo de Ponta Delgada is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Population was made of 66 individuals, aged 18-75 years who underwent general anesthesia with rocuronium (initial dose 0.6 mg/kg) neuromuscular blockade and subsequent reversal with sugammadex.
Exclusion Criteria:
Other: Dose of sugammadex according to SSD and QSD
Other: Dose of sugammadex according to SSD and QSD
At the time of pharmacologic reversal of the NMB, both the SSD and QSD, according to portuguese guidelines on the management of the NMB, were recorded. The QSD was then administered to the patient. The SSD was considered appropriate if it was within 10% of the recommended dose for the given depth of NMB, as measured by TOFscan® monitor. The results were analyzed descriptively.
The percentage of patients who would receive an adequate or inadequate (over or under) dose of sugammadex.
Given the interindividual variability response to neuromuscular block, which makes it difficult to subjectively determine the dose needed, the aim was to compare the sugammadex dose as suggested by senior anaesthesiologists based on clinical experience versus the dose determined by quantitative monitoring to determine if the subjective dose was appropriate.
Time frame: 3 months
Plan to share: No — Prospective, 3-month study in 66 patients aged 18-75 years who underwent general anesthesia with rocuronium neuromuscular block and reversal with sugammadex.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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