NCT01911520

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

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

Conditions

• Morbidly Obese Patients

Interventions

Type	Name	Description
DRUG	Sugammadex 2 mg/kg	Patients receive 2 mg/kg Sugammadex.
DRUG	Sugammadex. 4 mg/kg	Patients receive 4 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.

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2013-07-30
• Last updated: 2021-07-13

Locations

1 site across 1 country: Belgium