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

Condition(s) targeted: Morbidly Obese Patients.

Intervention: Sugammadex 2 mg/kg (Drug); Sugammadex. 4 mg/kg (Drug); Neuromuscular monitoring. (Procedure); Clinical evaluation of residual curarization . (Procedure)

Phase: Phase 2

Status: Completed

Sponsored by: University Hospital, Ghent

Official(s) and/or principal investigator(s):
Jurgen Van Limmen, MD, Principal Investigator, Affiliation: Ghent University Hospital
Luc De Baerdemaeker, MD, PhD, Principal Investigator, Affiliation: Ghent University Hospital
Koen Reyntjens, MD, Principal Investigator, Affiliation: Ghent University Hospital

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

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

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

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

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

Secondary outcome: Need/use of rescue medication at the end of surgery

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Ghent University Hospital, Ghent 9000, Belgium

Starting date: January 2011
Last updated: July 26, 2013