Sugammadex ED90 Dose in the Obese Patients
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|ClinicalTrials.gov Identifier: NCT02568345|
Recruitment Status : Completed
First Posted : October 5, 2015
Results First Posted : February 22, 2016
Last Update Posted : February 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Incomplete Reversal of Neuromuscular Block||Drug: sugammadex ED90||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sugammadex ED90 Dose to Reverse the Rocuronium Blockade in the Obese Patients|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||January 2014|
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 Name: ED90
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568345
|Study Director:||Lígia Andrade ST Mathias, MD, Ph.D||Full professor|