Clinical trial NCT04762420: Sugammadex Dosing: Anaesthesiologist Clinical Perception Versus Quantitative Monitoring
Official title: Sugammadex Dosing: Anaesthesiologist Clinical Perception Versus Quantitative Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuromuscular Blockade
Anesthesia
TOF
Curarization, Postoperative Residual
Lead sponsor: Hospital do Divino Espírito Santo de Ponta Delgada
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-75 years;
* Above patients who underwent general anesthesia with rocuronium neuromuscular blockade and subsequent reversal with sugammadex.

Exclusion Criteria:

* American Society of Anesthesiologists physical status V;
* Emergency surgery;
* Hypersensitivity history to rocuronium or sugammadex;
* Severe renal impairment/dialysis;
* Neuromuscular diseases;
* Severe hepatic disease;
* Pre-existing coagulopathies;
* Pregnancy.

Primary outcomes:
measure: The percentage of patients who would receive an adequate or inadequate (over or under) dose of sugammadex.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ponta Delgada
country: Portugal
facility: Hospital do Divino Espírito Santo
Study officials:
affiliation: Hospital do Divino Espírito Santo de Ponta Delgada
name: Paulo Frias, MD
role: PRINCIPAL_INVESTIGATOR
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