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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Brussel

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Decision date (initial)

2025-11-12

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

UZ Brussel

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacodynamic

The main objective is to compare the intubation conditions in morbidly obese patients (BMI ≥ 40 kg/m²) when using a rocuronium dose based on ideal body weight versus real body weight

Secondary objectives 7

1. Identifying the proportion of patients achieving clinically acceptable intubation conditions during RSI between IBW- and RBW-based rocuronium dosing.
2. Comparing the time to successful endotracheal intubation between groups.
3. Comparing the level of neuromuscular blockade at intubation.
4. Comparing the depth of anesthesia at intubation.
5. Comparing the need for adjunctive maneuvers/techniques to improve glottic view between groups.
6. Comparing oxygenation levels between groups before, during and after intubation.
7. Comparing the incidence of adverse events during RSI.

Conditions and MedDRA coding

Obesity

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Adult patients >= 18 years.
2. BMI ≥ 40 kg/m²
3. Scheduled for elective surgery requiring endotracheal intubation

Exclusion criteria 6

1. Known allergies for rocuronium bromide and/or the bromide ion.
2. Use of medications known to interfere with neuromuscular function
3. History of neuromuscular disorders
4. Pregnancy
5. Impaired hepatic or renal function
6. Non-elective procedures

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 7

1. 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.
2. 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.
3. Neuromuscular blockade level at intubation, assessed by train-of-four (TOF) response 45 seconds after flushing of the IV line
4. Use of adjunctive maneuvers or techniques (e.g., external laryngeal manipulation, use of bougie) required to improve the glottic view during intubation.
5. Use of additional maneuvers or techniques to improve glottis view
6. Oxygenation, defined by peripheral oxygen saturation (SpO₂): prior to pre-oxygenation, after pre-oxygenation, the lowest SpO₂ value observed during the intubation process
7. Incidence and nature of adverse events occurring during RSI, including: respiratory events (e.g., desaturation, bronchospasm), hemodynamic events (e.g., hypo- or hypertension),

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Brussel

Sponsor organisation

UZ Brussel

Address

Laarbeeklaan 101

City

Jette

Postcode

1090

Country

Belgium

Scientific contact point

Organisation

UZ Brussel

Contact name

Domien Vanhonacker

Public contact point

Organisation

UZ Brussel

Contact name

Domien Vanhonacker

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications