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Completed

NCT Number: NCT02545595

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU de Poitiers

Poitiers, 86021, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugammadex 1 mg/kg

Drug

Sugammadex 2 mg/kg

Drug

Sugammadex 4 mg/kg

Drug

Primary outcomes

  1. determine a profound neuromuscular blockade reversal on ideal body weight

    Time frame: 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 outcomes

  1. Compare dosages based on ideal body weight to real body weight

    Time frame: 30 minutes

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Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
First posted
Sep 10, 2015
Registry last updated
Oct 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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