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

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

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.

Study Overview

• Status: Completed
• Conditions: Morbidly Obese Patients
• Intervention / Treatment: Drug: Sugammadex 2 mg/kg; Procedure: Neuromuscular monitoring.; Procedure: Clinical evaluation of residual curarization .; Drug: Sugammadex. 4 mg/kg

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMI < 50, Total Body Weight (TBW), 2mg/kg; Patients with a BMI < 50, who will be dosed according to total body weight.	Drug: Sugammadex 2 mg/kg; Patients receive 2 mg/kg Sugammadex.; Procedure: Neuromuscular monitoring.; Neuromuscular monitoring using a TOF watch SX (Organon).; Procedure: Clinical evaluation of residual curarization .; Every 30 min, during the first 2 hours after the end of the surgery.
Experimental: BMI < 50, TBW, 4 mg/kg; Patients with a BMI < 50, who will be dosed according to total body weight.	Procedure: Neuromuscular monitoring.; Neuromuscular monitoring using a TOF watch SX (Organon).; Procedure: Clinical evaluation of residual curarization .; Every 30 min, during the first 2 hours after the end of the surgery.; Drug: Sugammadex. 4 mg/kg; Patients receive 4 mg/kg Sugammadex.
Experimental: BMI < 50, Ideal Body Weight (IBW), 2 mg/kg; Patients with a BMI < 50, who will be dosed according to ideal body weight.	Drug: Sugammadex 2 mg/kg; Patients receive 2 mg/kg Sugammadex.; Procedure: Neuromuscular monitoring.; Neuromuscular monitoring using a TOF watch SX (Organon).; Procedure: Clinical evaluation of residual curarization .; Every 30 min, during the first 2 hours after the end of the surgery.
Experimental: BMI < 50, IBW, 4 mg/kg; Patients with a BMI < 50, who will be dosed according to ideal body weight.	Procedure: Neuromuscular monitoring.; Neuromuscular monitoring using a TOF watch SX (Organon).; Procedure: Clinical evaluation of residual curarization .; Every 30 min, during the first 2 hours after the end of the surgery.; Drug: Sugammadex. 4 mg/kg; Patients receive 4 mg/kg Sugammadex.
Experimental: BMI > 50, TBW, 2mg/kg; Patients with a BMI > 50, who will be dosed according to total body weight.	Drug: Sugammadex 2 mg/kg; Patients receive 2 mg/kg Sugammadex.; Procedure: Neuromuscular monitoring.; Neuromuscular monitoring using a TOF watch SX (Organon).; Procedure: Clinical evaluation of residual curarization .; Every 30 min, during the first 2 hours after the end of the surgery.
Experimental: BMI > 50, TBW, 4mg/kg; Patients with a BMI > 50, who will be dosed according to total body weight.	Procedure: Neuromuscular monitoring.; Neuromuscular monitoring using a TOF watch SX (Organon).; Procedure: Clinical evaluation of residual curarization .; Every 30 min, during the first 2 hours after the end of the surgery.; Drug: Sugammadex. 4 mg/kg; Patients receive 4 mg/kg Sugammadex.
Experimental: BMI >50, IBW, 2 mg/kg; Patients with a BMI > 50, who will be dosed according to ideal body weight.	Drug: Sugammadex 2 mg/kg; Patients receive 2 mg/kg Sugammadex.; Procedure: Neuromuscular monitoring.; Neuromuscular monitoring using a TOF watch SX (Organon).; Procedure: Clinical evaluation of residual curarization .; Every 30 min, during the first 2 hours after the end of the surgery.
Experimental: BMI >50, IBW, 4 mg/kg; Patients with a BMI > 50, who will be dosed according to ideal body weight.	Procedure: Neuromuscular monitoring.; Neuromuscular monitoring using a TOF watch SX (Organon).; Procedure: Clinical evaluation of residual curarization .; Every 30 min, during the first 2 hours after the end of the surgery.; Drug: Sugammadex. 4 mg/kg; Patients receive 4 mg/kg Sugammadex.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to complete recovery of muscle relaxation, 30 minutes after end of surgery.	Measured with TOF Watch SX (TOF ratio > 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care.	30 minutes after end of surgery.
Time to complete recovery of muscle relaxation, 1 hour after the end of surgery.	Measured with TOF Watch SX (TOF ratio > 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care.	1hour after end of surgery.
Time to complete recovery of muscle relaxation, 1 hour 30 minutes after the end of surgery.	Measured with TOF Watch SX (TOF ratio > 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care.	1hour 30 minutes after end of surgery.
Time to complete recovery of muscle relaxation, 2 hours after the end of surgery.	Measured with TOF Watch SX (TOF ratio > 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care.	2 hours after end of surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need/use of rescue medication at the end of surgery	Additional administration of sugammadex 2 mg/kg Total Body Weight) at the end of surgery.	The hours following the end of surgery.

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Jurgen Van Limmen, MD, University Hospital, Ghent; Principal Investigator: Luc De Baerdemaeker, MD, PhD, University Hospital, Ghent; Principal Investigator: Koen Reyntjens, MD, University Hospital, Ghent

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: July 23, 2013
• First Submitted That Met QC Criteria: July 26, 2013
• First Posted (Estimate): July 30, 2013

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 2010/207; 2009-016857-16 (EudraCT Number)