Dose Finding Study for Effective Reversal of a Deep Rocuronium-induced Neuromuscular Block With Sugammadex in Morbidly Obese Patients (BRIDION)

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 2

Conditions: Morbidly Obese Patients

Treatments: Procedure: Neuromuscular monitoring.; Drug: Sugammadex. 4 mg/kg; Drug: Sugammadex 2 mg/kg; Procedure: Clinical evaluation of residual curarization .

Study type: Interventional

Funder types: Other

Identifiers

NCT01911520

2009-016857-16 (EudraCT Number)

2010/207

Details and patient eligibility

About

During laparoscopic bariatric surgery, adequate muscle relaxation is important to maintain good surgical conditions. To achieve this muscle relaxation, neuromuscular transmission blocking agents, such as rocuronium (Esmeron®) are used. It sometimes happens that there is still some neuromuscular blocking activity left in the patient on awakening from anesthesia. This is called residual curarization and is known to cause postoperative complications such as impairment of respiratory function.

Sugammadex (Bridion®) is a novel drug which selectively binds rocuronium (Esmeron®). It allows for reversing of neuromuscular transmission blocking activity. Until now, all studies with sugammadex were performed in non-obese patients.

Obese patient have a high risk to suffer from post-operative respiratory failure. Therefore it is vital to avoid residual curarization. Sugammadex might be an important factor.

Obese patients have a large total body weight different from ideal body weight. Recent research demonstrated that the dose for the neuromuscular blocking agent rocuronium (Esmeron®) needs to be calculated on the patients' Ideal Body Weight rather than on Total Body Weight.

At this moment no data is available on the dose-response relationship of sugammadex in morbidly obese patients.

We hypothesize that in morbidly obese patients sugammadex should be dosed on ideal bodyweight, instead of total bodyweight.

Full description

Flowchart :

72 participants

Stratification

BMI<50 BMI >50

Randomization Randomization

TBW IBW TBW IBW

2mg/kg n=9 2mg/kg n=9 2mg/kg n=9 2mg/kg n=9 4mg/kg n=9 4mg/kg n=9 4mg/kg n=9 4mg/kg n=9

TBW : Total Body Weight IBW : Ideal Body Weight

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria :

• ASA I-II-III
• Age 18 - 65 year
• Male or female
• BMI > 30

Exclusion criteria :

• Renal failure
• Liver dysfunction
• Breastfeeding female patients, or female patients without reliable contraception
• Neuromuscular disease
• Malignant hyperthermia or a family history of malignant hyperthermia
• Allergy for neuromuscular blocking agents or other medications used during general anesthesia
• Infectious disease or patients with fever
• Patients who already received rocuronium or sugammadex on the day of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 8 patient groups

BMI < 50, Total Body Weight (TBW), 2mg/kg

Experimental group

Description:

Patients with a BMI \< 50, who will be dosed according to total body weight.

Treatment:

Procedure: Clinical evaluation of residual curarization .

Drug: Sugammadex 2 mg/kg

Procedure: Neuromuscular monitoring.

BMI < 50, TBW, 4 mg/kg

Experimental group

Description:

Patients with a BMI \< 50, who will be dosed according to total body weight.

Treatment:

Procedure: Clinical evaluation of residual curarization .

Drug: Sugammadex. 4 mg/kg

Procedure: Neuromuscular monitoring.

BMI < 50, Ideal Body Weight (IBW), 2 mg/kg

Experimental group

Description:

Patients with a BMI \< 50, who will be dosed according to ideal body weight.

Treatment:

Procedure: Clinical evaluation of residual curarization .

Drug: Sugammadex 2 mg/kg

Procedure: Neuromuscular monitoring.

BMI < 50, IBW, 4 mg/kg

Experimental group

Description:

Patients with a BMI \< 50, who will be dosed according to ideal body weight.

Treatment:

Procedure: Clinical evaluation of residual curarization .

Drug: Sugammadex. 4 mg/kg

Procedure: Neuromuscular monitoring.

BMI > 50, TBW, 2mg/kg

Experimental group

Description:

Patients with a BMI \> 50, who will be dosed according to total body weight.

Treatment:

Procedure: Clinical evaluation of residual curarization .

Drug: Sugammadex 2 mg/kg

Procedure: Neuromuscular monitoring.

BMI > 50, TBW, 4mg/kg

Experimental group

Description:

Patients with a BMI \> 50, who will be dosed according to total body weight.

Treatment:

Procedure: Clinical evaluation of residual curarization .

Drug: Sugammadex. 4 mg/kg

Procedure: Neuromuscular monitoring.

BMI >50, IBW, 2 mg/kg

Experimental group

Description:

Patients with a BMI \> 50, who will be dosed according to ideal body weight.

Treatment:

Procedure: Clinical evaluation of residual curarization .

Drug: Sugammadex 2 mg/kg

Procedure: Neuromuscular monitoring.

BMI >50, IBW, 4 mg/kg

Experimental group

Description:

Patients with a BMI \> 50, who will be dosed according to ideal body weight.

Treatment:

Procedure: Clinical evaluation of residual curarization .

Drug: Sugammadex. 4 mg/kg

Procedure: Neuromuscular monitoring.