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Rocuronium Infusion with Sugammadex vs Bolus with Neostigmine in Laparotomy

NCT01539044Phase 4

Key facts

Status: Completed
Start: Feb 2012
Primary completion: Jun 2013
Countries: 1
Sponsor: Hospital Sultanah Aminah
Modality: Biodegradable Polymers, Small Molecules

Drugs: Sugammadex
Conditions: neuromuscular blockade (NMB)

Overview

Phase 4, randomised, double-blind trial of Sugammadex in neuromuscular blockade (NMB) (2 arms), sponsored by Hospital Sultanah Aminah. Primary endpoint: Time to full reversal of neuromuscular blockade at 30 minutes. Started Feb 2012; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

CI-Sugammadex
Continuous Rocuronium + Sugammadex
IB-Neostigmine
Intermittent Rocuronium + Neostigmine

Endpoints

Primary

Time to full reversal of neuromuscular blockade30 minutes

Secondary

Vital signs (heart rate and blood pressure)24 hours
Incidence of intraoperative events3 hours
Incidence of residual neuromuscular blockade1 hour
Surgeon's assessment of quality of relaxationEnd of surgery

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