CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 31 enrolled
Drug / intervention
sugammadex ED90drug
Likely dose
sugammadex ED90 2.4 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02568345
NCT02568345Phase 4Completed
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Sugammadex ED90 Dose to Reverse the Rocuronium Blockade in the Obese Patients

Faculdade de Ciências Médicas da Santa Casa de São Paulo·interventional·Posted Oct 5, 2015·Updated Feb 22, 2016

In Brief

A Phase 4 clinical trial evaluating sugammadex ED90 for Incomplete Reversal of Neuromuscular Block. Completed, enrolled 31 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIncomplete Reversal of Neuromuscular Block
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 5, 2015
Enrollment StartJan 1, 2013
Primary CompletionOct 1, 2013
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.7 years ago

Interventions

sugammadex ED90drug

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.