Sugammadex ED90 Dose in the Obese Patients

NCT02568345 | Completed Phase 4 Results

• 1 other identifier: 191.837
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Incomplete Reversal of Neuromuscular Block

Keywords

Dose-Response Relationship; Drug; Obesity; Cyclodextrins

Outcome Measures

Primary Outcomes (1)

• Sugammadex ED90

  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

Study Arms (1)

sugammadex ED90

EXPERIMENTAL

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

Interventions

sugammadex ED90 DRUG

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.

Also known as: ED90

sugammadex ED90

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Faculdade de Ciências Médicas da Santa Casa de São Paulo: lead

Related Publications (26)

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MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mauro Prado da Silva
• Organization: Central Hospital, Irmandade da Santa Casa de Misericórdia (ISCM)

comissaocientifica@fcmsantacasasp.edu.br

+55 11 2176 7000

Study Officials

• Lígia Andrade ST Mathias, MD, Ph.D

  Full professor

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Staff

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: October 5, 2015
• Study Start: January 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: January 1, 2014
• Last Updated: February 22, 2016
• Results First Posted: February 22, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will share