Dose finding study for effective reversal of a moderate rocuronium-induced neuromuscular block with sugammadex in morbidly obese patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-016857-16-BE

Enrollment

Registered

2010-04-14

Start date

2010-06-09

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbidly obese patients

Interventions

Trade Name: Bridion Product Name: Sugammadex Pharmaceutical Form: Solution for injection INN or Proposed INN: SUGAMMADEX CAS Number: 343306-71-8 Concentration unit: mg/ml milligram(s)/millilitre Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - ASA I-II-III - Age 18 – 65 year - Male or female - BMI > 30 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Renal failure - Liverdysfunction - Breastfeeding female patients, or female patients without reliable contraception - Neuromuscular disease - Malignant hyperthermia or a famliy history of malignant hyperthermia - Allergy for neuromuscular blocking agents or other medications used during general anesthesia - Infectious disease or patients with fever - Patients who already received rocuronium or sugammadex on the day of the study

Design outcomes

Primary

Measure	Time frame
Main Objective: should sugammadex be dosed on total body weight (TBW) or ideal body weight (IBW) in morbidly obese patients?;Secondary Objective: Is there a risk on residual curarization ?;Primary end point(s): Dose-response relationship of sugammadex in morbidly obese patients	—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026