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Dose Finding Study for Effective Reversal of a Deep Rocuronium-induced Neuromuscular Block With Sugammadex in Morbidly Obese Patients

Dose Finding Study for Effective Reversal of a Deep Rocuronium-induced Neuromuscular Block With Sugammadex in Morbidly Obese Patients.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01911520
Acronym
BRIDION
Enrollment
40
Registered
2013-07-30
Start date
2011-01-31
Completion date
2012-06-30
Last updated
2021-07-13

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

Conditions

Morbidly Obese Patients

Brief summary

During laparoscopic bariatric surgery, adequate muscle relaxation is important to maintain good surgical conditions. To achieve this muscle relaxation, neuromuscular transmission blocking agents, such as rocuronium (Esmeron®) are used. It sometimes happens that there is still some neuromuscular blocking activity left in the patient on awakening from anesthesia. This is called residual curarization and is known to cause postoperative complications such as impairment of respiratory function. Sugammadex (Bridion®) is a novel drug which selectively binds rocuronium (Esmeron®). It allows for reversing of neuromuscular transmission blocking activity. Until now, all studies with sugammadex were performed in non-obese patients. Obese patient have a high risk to suffer from post-operative respiratory failure. Therefore it is vital to avoid residual curarization. Sugammadex might be an important factor. Obese patients have a large total body weight different from ideal body weight. Recent research demonstrated that the dose for the neuromuscular blocking agent rocuronium (Esmeron®) needs to be calculated on the patients' Ideal Body Weight rather than on Total Body Weight. At this moment no data is available on the dose-response relationship of sugammadex in morbidly obese patients. We hypothesize that in morbidly obese patients sugammadex should be dosed on ideal bodyweight, instead of total bodyweight.

Detailed description

Flowchart : 72 participants Stratification BMI\<50 BMI \>50 Randomization Randomization TBW IBW TBW IBW 2mg/kg n=9 2mg/kg n=9 2mg/kg n=9 2mg/kg n=9 4mg/kg n=9 4mg/kg n=9 4mg/kg n=9 4mg/kg n=9 TBW : Total Body Weight IBW : Ideal Body Weight

Interventions

Patients receive 2 mg/kg Sugammadex.

DRUGSugammadex. 4 mg/kg

Patients receive 4 mg/kg Sugammadex.

PROCEDURENeuromuscular monitoring.

Neuromuscular monitoring using a TOF watch SX (Organon).

PROCEDUREClinical evaluation of residual curarization .

Every 30 min, during the first 2 hours after the end of the surgery.

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

: * ASA I-II-III * Age 18 - 65 year * Male or female * BMI \> 30

Exclusion criteria

: * Renal failure * Liver dysfunction * Breastfeeding female patients, or female patients without reliable contraception * Neuromuscular disease * Malignant hyperthermia or a family 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

MeasureTime frameDescription
Time to complete recovery of muscle relaxation, 30 minutes after end of surgery.30 minutes after end of surgery.Measured with TOF Watch SX (TOF ratio \> 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care.
Time to complete recovery of muscle relaxation, 1 hour after the end of surgery.1hour after end of surgery.Measured with TOF Watch SX (TOF ratio \> 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care.
Time to complete recovery of muscle relaxation, 1 hour 30 minutes after the end of surgery.1hour 30 minutes after end of surgery.Measured with TOF Watch SX (TOF ratio \> 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care.
Time to complete recovery of muscle relaxation, 2 hours after the end of surgery.2 hours after end of surgery.Measured with TOF Watch SX (TOF ratio \> 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care.

Secondary

MeasureTime frameDescription
Need/use of rescue medication at the end of surgeryThe hours following the end of surgery.Additional administration of sugammadex 2 mg/kg Total Body Weight) at the end of surgery.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026