Sugammadex Dosing: Anaesthesiologist Clinical Perception Versus Quantitative Monitoring

February 16, 2021 updated by: Ernesto Ruivo, Hospital do Divino Espírito Santo de Ponta Delgada
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.

Study Overview

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 Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ponta Delgada, Portugal, 9500-370
        • Hospital do Divino Espírito Santo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sugammadex dose as suggested by senior anaesthesiologists (SSD) based on clinical experience.
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.
Dose of Sugammadex determined by quantitative monitoring (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Paulo Frias, MD, Hospital Do Divino Espirito Santo De Ponta Delgada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

April 30, 2019

Study Registration Dates

First Submitted

February 10, 2021

First Submitted That Met QC Criteria

February 16, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • DivinoEspíritoSanto

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Prospective, 3-month study in 66 patients aged 18-75 years who underwent general anesthesia with rocuronium neuromuscular block and reversal with sugammadex.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anesthesia

Clinical Trials on Dose of sugammadex according to SSD and QSD

3
Subscribe