Morbidly Obese Patients
Conditions
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.
Patients receive 4 mg/kg Sugammadex.
Neuromuscular monitoring using a TOF watch SX (Organon).
Every 30 min, during the first 2 hours after the end of the surgery.
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Need/use of rescue medication at the end of surgery | The hours following the end of surgery. | Additional administration of sugammadex 2 mg/kg Total Body Weight) at the end of surgery. |
Countries
Belgium