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NCT Number: NCT01911520

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugammadex 2 mg/kg

Drug

Patients receive 2 mg/kg Sugammadex.

Sugammadex. 4 mg/kg

Drug

Patients receive 4 mg/kg Sugammadex.

Neuromuscular monitoring.

Procedure

Neuromuscular monitoring using a TOF watch SX (Organon).

Clinical evaluation of residual curarization .

Procedure

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

Primary outcomes

  1. Time to complete recovery of muscle relaxation, 30 minutes after end of surgery.

    Time frame: 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.

  2. Time to complete recovery of muscle relaxation, 1 hour after the end of surgery.

    Time frame: 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.

  3. Time to complete recovery of muscle relaxation, 1 hour 30 minutes after the end of surgery.

    Time frame: 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.

  4. Time to complete recovery of muscle relaxation, 2 hours after the end of surgery.

    Time frame: 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 outcomes

  1. Need/use of rescue medication at the end of surgery

    Time frame: The hours following the end of surgery.

    Additional administration of sugammadex 2 mg/kg Total Body Weight) at the end of surgery.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Acronym: BRIDION

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 30, 2013
Registry last updated
Jul 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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