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

NCT ID: NCT02545595

Last Updated: 2016-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31

Brief 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

Study Groups

Sugammadex 1mg/kg

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

Group Type: EXPERIMENTAL

Sugammadex 1 mg/kg

Intervention Type: DRUG

Sugammadex 2mg/kg

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

Group Type: EXPERIMENTAL

Sugammadex 2 mg/kg

Intervention Type: DRUG

Sugammadex 4mg/kg

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

Group Type: EXPERIMENTAL

Sugammadex 4 mg/kg

Intervention Type: DRUG

Interventions

Sugammadex 1 mg/kg

Intervention Type: DRUG

Sugammadex 2 mg/kg

Intervention Type: DRUG

Sugammadex 4 mg/kg

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Poitiers

Poitiers, , France

Countries

France

Other Identifiers

OBRITI

Identifier Type: -

Identifier Source: org_study_id