Ghent University Hospital
Ghent, 9000, Belgium
NCT Number: NCT01911520
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Phase 2
Ghent, 9000, Belgium
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 frame: 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: 1hour 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: 1hour 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: 2 hours 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: The hours following the end of surgery.
Additional administration of sugammadex 2 mg/kg Total Body Weight) at the end of surgery.
University Hospital, Ghent
Other
Dose Finding Study for Effective Reversal of a Deep Rocuronium-induced Neuromuscular Block With Sugammadex in Morbidly Obese Patients.
Acronym: BRIDION
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.
Published trials that share one or more normalized conditions with this study.
NCT07175155
Digestive System Diseases, Digestive System Neoplasms
Beijing, Beijing Municipality, China
View Trial Details