NCT02545595

Sugammadex Dosage Based on Ideal Body Weight for Profound Rocuronium-induced Neuromuscular Blockade Reversal in Morbidly Obese Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This randomized double blind clinical trial focuses on patients with Body Masse Index ≥ 40 kg/m2, undergoing scheduled surgery. Neuromuscular transmission monitoring at the adductor is performed using. Anaesthesia is induced with anaesthesic and maintained with curare. At the end of the procedure, patients with profound neuromuscular blockade receive either 1 mg/kg, 2 mg/kg or 4 mg/kg Sugammadex based on ideal body weight. A complete reversal failure is defined by a Train Of Four ratio \< 0.9 within 10 min after administration of Sugammadex or if recurarization occurs within 15 min after complete reversal success.

Conditions

• Morbid Obesity

Interventions

Type	Name	Description
DRUG	Sugammadex 1 mg/kg
DRUG	Sugammadex 2 mg/kg
DRUG	Sugammadex 4 mg/kg

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-12-01
• First posted: 2015-09-10
• Last updated: 2016-10-12

Locations

1 site across 1 country: France