Sugammadex Dosing: Anaesthesiologist Clinical Perception Versus Quantitative Monitoring

Completed

• Conditions: TOF; Curarization, Postoperative Residual; Neuromuscular Blockade; Anesthesia
• Interventions: Other: Dose of sugammadex according to SSD and QSD

• Registration Number: NCT04762420
• Lead Sponsor: Hospital do Divino Espírito Santo de Ponta Delgada

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.

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2021-02
• Study First Submitted: 2021-02-10
• Study First Submitted QC: 2021-02-16
• Last Update Submitted: 2021-02-16
• Study First Posted: 2021-02-21
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sugammadex dose as suggested by senior anaesthesiologists (SSD) based on clinical experience.	Dose of sugammadex according to SSD and QSD	-
Dose of Sugammadex determined by quantitative monitoring (QSD).	Dose of sugammadex according to SSD and QSD	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hospital do Divino Espírito Santo; 🇵🇹 Ponta Delgada, Portugal