Comparison of Rocuronium Bromide Dosing Based on Ideal Versus Actual Body Weight for Intubation in Morbidly Obese Patients with Propofol and Sodium Chloride

The primary objective is to compare intubation conditions in patients with morbid obesity (BMI ≥ 40 kg/m²) when administering rocuronium based on ideal body weight versus real body weight during rapid sequence induction. Secondary objectives include:

• The proportion of patients achieving clinically acceptable intubation conditions.
• The time to successful endotracheal intubation.
• The level of neuromuscular blockade and depth of anesthesia at the time of intubation.
• The requirement for adjunctive maneuvers or techniques to improve the glottic view.
• Oxygenation levels before, during, and after intubation.
• The incidence of adverse events during the induction process.

The sponsor did not provide information regarding the total number of participants. The study population consists of adult patients, aged 18 years or older, including both males and females. Eligible individuals are those diagnosed with obesity, specifically defined by a body mass index of 40 kg/m² or greater. Participants are selected based on being scheduled for elective surgery that necessitates endotracheal intubation. The investigation focuses on comparing intubation conditions in these patients when utilizing rocuronium dosages calculated according to ideal body weight versus real body weight.

This study is designed as a comparative clinical trial to evaluate intubation conditions in patients with obesity (BMI ≥ 40 kg/m²) undergoing rapid sequence induction. The research compares the administration of rocuronium bromide at a dose calculated based on ideal body weight versus a dose based on real body weight. Participants must be adults aged 18 years or older scheduled for elective surgery requiring endotracheal intubation. The primary endpoint is the achievement of excellent intubation conditions. Secondary endpoints include the proportion of patients achieving clinically acceptable conditions according to the Fuchs–Borgeat scale, time to successful intubation, neuromuscular blockade level assessed by train-of-four response, and the requirement for adjunctive maneuvers. Additional parameters include oxygenation measured via peripheral oxygen saturation and the incidence of adverse events. The study involves a screening phase to confirm eligibility, followed by the induction and intubation procedures, and concludes with the observation of clinical outcomes. The total recruitment and study period is estimated to occur between October 2025 and December 2028.

The experimental treatment consists of rocuronium bromide, provided as a solution for injection/infusion. The administration is performed via injection at a dosage of 2 mg/kg.

Auxiliary treatments include propofol, administered as an emulsion for injection/infusion at a dose of 12 mg/kg via injection. Additionally, sodium chloride is utilized as a solution for injection at a dose of 6 mmol/kg through injection.

The primary efficacy endpoint is the achievement of excellent intubation conditions during rapid sequence induction in patients with obesity, comparing rocuronium bromide dosing based on ideal body weight versus real body weight.

Secondary endpoints include:

• The proportion of patients achieving clinically acceptable intubation conditions, categorized as excellent or good according to the Fuchs–Borgeat scale.
• Time to successful endotracheal intubation, measured from the initiation of rocuronium injection until confirmation via capnography.
• The level of neuromuscular blockade at intubation, assessed by the train-of-four response 45 seconds after flushing the intravenous line.
• The requirement for adjunctive maneuvers or techniques, such as external laryngeal manipulation or the use of a bougie, to improve the glottic view.
• Oxygenation status, defined by peripheral oxygen saturation at three specific points: prior to pre-oxygenation, after pre-oxygenation, and the lowest value observed during the intubation process.
• The incidence and nature of adverse events during rapid sequence induction, including respiratory events such as desaturation or bronchospasm, and hemodynamic events such as hypotension or hypertension.