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

Poitiers University Hospital

Status and phase: Completed; Phase 2

Conditions: Morbid Obesity

Treatments: Drug: Sugammadex 2 mg/kg; Drug: Sugammadex 4 mg/kg; Drug: Sugammadex 1 mg/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT02545595

OBRITI

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• General anaesthesia
• Neuromuscular blockade induce by rocuronium
• Body Masse Indice ≥ 40 kg/m2
• informed consent

Exclusion criteria

• Contraindication to rocuronium or sugammadex
• Pregnant women
• Severe renal insufficiency

Trial design

0 participants in 3 patient groups

Sugammadex 1mg/kg

Experimental group

Description:

for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients

Treatment:

Drug: Sugammadex 1 mg/kg

Sugammadex 2mg/kg

Experimental group

Description:

for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients

Treatment:

Drug: Sugammadex 2 mg/kg

Sugammadex 4mg/kg

Experimental group

Description:

for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients

Treatment:

Drug: Sugammadex 4 mg/kg