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

NCT02545595 | Completed Phase 2

• 1 other identifier: OBRITI
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

General anaesthesia; Curarization with rocuronium

Outcome Measures

Primary Outcomes (1)

• determine a profound neuromuscular blockade reversal 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

  30 minutes

Secondary Outcomes (1)

• Compare dosages based on ideal body weight to real body weight

  30 minutes

Study Arms (3)

Sugammadex 1mg/kg

EXPERIMENTAL

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

Drug: Sugammadex 1 mg/kg

Sugammadex 2mg/kg

EXPERIMENTAL

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

Drug: Sugammadex 2 mg/kg

Sugammadex 4mg/kg

EXPERIMENTAL

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

Drug: Sugammadex 4 mg/kg

Interventions

Sugammadex 1 mg/kg DRUG

Sugammadex 1mg/kg

Sugammadex 2 mg/kg DRUG

Sugammadex 2mg/kg

Sugammadex 4 mg/kg DRUG

Sugammadex 4mg/kg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU de Poitiers

Poitiers, 86021, France

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Sugammadex

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: September 10, 2015
• Study Start: May 1, 2012
• Primary Completion: December 1, 2013
• Last Updated: October 12, 2016

Record last verified: 2016-10

Locations

FR (1)