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Completed

NCT Number: NCT04762420

Sugammadex Dosing: Anaesthesiologist Clinical Perception Versus Quantitative Monitoring

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital do Divino Espírito Santo

Ponta Delgada, 9500-370, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dose of sugammadex according to SSD and QSD

Other

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.

Primary outcomes

  1. The percentage of patients who would receive an adequate or inadequate (over or under) dose of sugammadex.

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Hospital do Divino Espírito Santo de Ponta Delgada

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 21, 2021
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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