Sugammadex ED90 Dose in the Obese Patients

January 22, 2016 updated by: Mauro Prado da Silva, Faculdade de Ciências Médicas da Santa Casa de São Paulo

Sugammadex ED90 Dose to Reverse the Rocuronium Blockade in the Obese Patients

The purpose of this study is to determine the minimum effective dose of sugammadex, an antagonist of neuromuscular blockade used during anesthesia practice, in obese patients, considering that sugammadex is indicated in adults with normal weight at a dose of 2 mg/kg but no studies were found with obese patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective study with the sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).

The following doses were chosen: 2.0 mg.kg-1, 2.2 mg.kg-1, 2.4 mg.kg-1, 2.6 mg.kg-1, 2.8 mg.kg-1.

The complete reversal of moderate rocuronium-induced neuromuscular blockade (NMB) considered a T4/T1 ratio ≥ 0.9 with the peripheral nerve stimulator and accelerometer (monitor of sequential electric stimuli) "train-of-four" (TOF).

After induction of general anesthesia and the calibration of the peripheral nerve stimulator and accelerometer, rocuronium 0.6 mg.kg-1 was injected.

Continuous intravenous infusion of the anesthetics propofol and remifentanil, and intermittent bolus of rocuronium were offered throughout the procedure.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 4

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 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • a body mass index ≥ 40 kg/m2
  • bariatric surgery
  • informed consent signed

Exclusion Criteria:

  • history of neuromuscular diseases,
  • use of drugs that could interfere with neuromuscular transmission,
  • allergy to neuromuscular agents of the aminosteroids class,
  • anticipated difficulty in airway management,
  • renal failure

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

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: sugammadex ED90

Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).

The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg.
Drug: sugammadex ED90

The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.

In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg.

Other Names:
  • ED90

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sugammadex ED90
Time Frame: 8 minutes

Complete reversal of neuromuscular blockade occured when the patient had a TOF T4/T1 ≥ 0.9 within eight minutes of sugammadex infusion.

The sequencial design method of up-and-down was applied to determine the minimum effective dose in 90% of patients (ED90). An effective dose is one that achieves complete reversal of neuromuscular blockade that is defined as a measure of TOF equal or higher than 0.9, or a relationship between T4 an T1 measure ≥ 0.9, within eight minutes of sugammadex infusion.
8 minutes

Collaborators and Investigators

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

Sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Investigators

  • Study Director: Lígia Andrade ST Mathias, MD, Ph.D, Full Professor

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

January 1, 2013

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

October 2, 2015

First Submitted That Met QC Criteria

October 2, 2015

First Posted (ESTIMATE)

October 5, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

February 22, 2016

Last Update Submitted That Met QC Criteria

January 22, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 191.837

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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.

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