Rocuronium bromide for Obesity

Inclusion criteria

• {"criterion_text":"-Adult patients >= 18 years."}
• {"criterion_text":"-BMI ≥ 40 kg/m²"}
• {"criterion_text":"-Scheduled for elective surgery requiring endotracheal intubation"}

Exclusion criteria

• {"criterion_text":"-Known allergies for rocuronium bromide and/or the bromide ion."}
• {"criterion_text":"-Use of medications known to interfere with neuromuscular function"}
• {"criterion_text":"-History of neuromuscular disorders"}
• {"criterion_text":"-Pregnancy"}
• {"criterion_text":"-Impaired hepatic or renal function"}
• {"criterion_text":"-Non-elective procedures"}

Primary endpoints

• {"endpoint_text":"-Achievement of excellent intubation conditions during Rapid Sequence Induction in morbidly obese patients through the administration of rocuronium based on Ideal Body Weight or Real Body Weight.","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"-Proportion of patients achieving clinically acceptable intubation conditions, defined as excellent or good according to the Fuchs–Borgeat scale, during rapid sequence induction (RSI) following rocuronium administration based on IBW or RBW.","definition_or_measurement_approach":"Defined as excellent or good according to the Fuchs–Borgeat scale."}
• {"endpoint_text":"-Time to successful endotracheal intubation, measured from the start of rocuronium injection (flushing of the IV line) until confirmation of intubation by the first capnography trace consistent with endotracheal placement.","definition_or_measurement_approach":"Measured from start of rocuronium injection (flushing of IV line) to first capnography trace confirming endotracheal placement."}
• {"endpoint_text":"-Neuromuscular blockade level at intubation, assessed by train-of-four (TOF) response 45 seconds after flushing of the IV line","definition_or_measurement_approach":"Assessed by train-of-four (TOF) response at 45 seconds after flushing of the IV line."}
• {"endpoint_text":"-Comparing the depth of anesthesia at intubation.","definition_or_measurement_approach":""}
• {"endpoint_text":"-Comparing the need for adjunctive maneuvers/techniques to improve glottic view between groups.","definition_or_measurement_approach":""}
• {"endpoint_text":"-Oxygenation, defined by peripheral oxygen saturation (SpO₂): prior to pre-oxygenation, after pre-oxygenation, the lowest SpO₂ value observed during the intubation process","definition_or_measurement_approach":"Oxygenation measured by peripheral oxygen saturation (SpO₂) before pre-oxygenation, after pre-oxygenation, and the lowest SpO₂ during intubation."}
• {"endpoint_text":"-Incidence and nature of adverse events occurring during RSI, including: respiratory events (e.g., desaturation, bronchospasm), hemodynamic events (e.g., hypo- or hypertension),","definition_or_measurement_approach":"Collected incidence and nature of adverse events during RSI; examples include respiratory and hemodynamic events."}

Belgium

Earliest CTIS Part Ii Submission Date

08-10-2025

Latest Decision Or Authorization Date

12-11-2025

Processing Time Days

35

Number Of Sites

3

Number Of Participants

182

Primary sponsor

Full Name

UZ Brussel

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium