A Phase 2 interventional study of Sugammadex 2 mg/kg and Sugammadex. 4 mg/kg in Morbidly Obese Patients, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-07-13.
Sponsored by University Hospital, Ghent · Phase 2, Interventional, and Treatment
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.
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
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 40 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria :
Patients with a BMI \< 50, who will be dosed according to total body weight.
Drug: Sugammadex 2 mg/kg · Procedure: Neuromuscular monitoring. · Procedure: Clinical evaluation of residual curarization .
Patients with a BMI \< 50, who will be dosed according to total body weight.
Drug: Sugammadex. 4 mg/kg · Procedure: Neuromuscular monitoring. · Procedure: Clinical evaluation of residual curarization .
Patients with a BMI \< 50, who will be dosed according to ideal body weight.
Drug: Sugammadex 2 mg/kg · Procedure: Neuromuscular monitoring. · Procedure: Clinical evaluation of residual curarization .
Patients with a BMI \< 50, who will be dosed according to ideal body weight.
Drug: Sugammadex. 4 mg/kg · Procedure: Neuromuscular monitoring. · Procedure: Clinical evaluation of residual curarization .
Patients with a BMI \> 50, who will be dosed according to total body weight.
Drug: Sugammadex 2 mg/kg · Procedure: Neuromuscular monitoring. · Procedure: Clinical evaluation of residual curarization .
Patients with a BMI \> 50, who will be dosed according to total body weight.
Drug: Sugammadex. 4 mg/kg · Procedure: Neuromuscular monitoring. · Procedure: Clinical evaluation of residual curarization .
Patients with a BMI \> 50, who will be dosed according to ideal body weight.
Drug: Sugammadex 2 mg/kg · Procedure: Neuromuscular monitoring. · Procedure: Clinical evaluation of residual curarization .
Patients with a BMI \> 50, who will be dosed according to ideal body weight.
Drug: Sugammadex. 4 mg/kg · Procedure: Neuromuscular monitoring. · Procedure: Clinical evaluation of residual curarization .
Patients receive 2 mg/kg Sugammadex.
Patients receive 4 mg/kg Sugammadex.
Neuromuscular monitoring using a TOF watch SX (Organon).
Every 30 min, during the first 2 hours after the end of the surgery.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 hours after end of surgery.
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.
Time frame: The hours following the end of surgery.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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University Hospital, Ghent