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Clinical Trials in the EU / 2025-520977-37-00
Authorised Phase IV

Intubation Conditions in Morbidly Obese Patients with Rapid Sequence Induction: A Comparative Study of Rocuronium Dosing based on Ideal vs. Real Body Weight

2025-520977-37-00 · tracked via the Priya Life Science EU tracker
Sponsor
UZ Brussel
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Anesthesia and Analgesia
Decision date
12/11/2025
Enrollment target
182
Sites
Belgium

Condition studied

Obesity

Investigational medicinal product(s)

NaCl 09 % B. BraunInjektionslösungPropofol B. Braun 1% (10 mg/ml)emulsie voor injectie of infusieRocuroniumbromide Fresenius Kabi 10 mg/ml oplossing voor injectie / infusie

Eligibility

Age group
18-64 years, 65+ years
Sex
Female, Male

Primary endpoint

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.

Endpoint detail

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., 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., Neuromuscular blockade level at intubation, assessed by train-of-four (TOF) response 45 seconds after flushing of the IV line, Use of adjunctive maneuvers or techniques (e.g., external laryngeal manipulation, use of bougie) required to improve the glottic view during intubation., Use of additional maneuvers or techniques to improve glottis view, Oxygenation, defined by peripheral oxygen saturation (SpO₂): prior to pre-oxygenation, after pre-oxygenation, the lowest SpO₂ value observed during the intubation process, Incidence and nature of adverse events occurring during RSI, including: respiratory events (e.g., desaturation, bronchospasm), hemodynamic events (e.g., hypo- or hypertension),

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-520977-37-00 on CTIS ↗ ← All trials in the EU