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

Phase 2

Completed

• Conditions: Morbid Obesity
• Interventions: Drug: Sugammadex 4 mg/kg; Drug: Sugammadex 1 mg/kg; Drug: Sugammadex 2 mg/kg

• Registration Number: NCT02545595
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2013-03-27
• Primary Completion: 2013-12
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sugammadex 4mg/kg	Sugammadex 4 mg/kg	for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients
Sugammadex 1mg/kg	Sugammadex 1 mg/kg	for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients
Sugammadex 2mg/kg	Sugammadex 2 mg/kg	for profound rocuronium-induced neuromuscular blockade reversal in morbidly obese patients

Primary Outcome Measures

Name	Time	Method
determine a profound neuromuscular blockade reversal on ideal body weight	30 minutes	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

Secondary Outcome Measures

Name	Time	Method
Compare dosages based on ideal body weight to real body weight	30 minutes

Trial Locations

Locations (1)

CHU de Poitiers; 🇫🇷 Poitiers, France