Sugammadex ED90 Dose in the Obese Patients

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Status and phase: Completed; Phase 4

Conditions: Incomplete Reversal of Neuromuscular Block

Treatments: Drug: sugammadex ED90

Study type: Interventional

Funder types: Other

Identifiers

NCT02568345

191.837

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

sugammadex ED90

Experimental group

Description:

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.

Treatment:

Drug: sugammadex ED90