CURES: The Effect of Deep Curarisation and Reversal With Sugammadex on Surgical Conditions and Perioperative Morbidity
Condition: Obesity; Laparoscopic Gastric Bypass Surgery; Surgical Conditions; Respiratory Function; Cerebral Tissue Oxygenation
MeSH terms: Disease
Intervention: deep neuromuscular blockade with rocuronium, reversal with sugammadex; normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine
Intervention description: after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9.; After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9.
Intervention MeSH terms: Glycopyrrolate; Rocuronium; Neostigmine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate if a deep neuromuscular block with a continuous
      infusion of rocuronium titrated to a post-tetanic count (PTC) of 1-2 responses combined with
      reversal of neuromuscular blockade with sugammadex results in improved surgical conditions
      for the surgeon and/or improved post-operative respiratory function for the patients as
      compared to a standard technique with an intubation dose of rocuronium and top-ups as needed
      to maintain a neuromuscular blockade with a train of four (TOF) count of 1-2 and reversal of
      neuromuscular blockade with neostigmine/glycopyrrolate.

      Furthermore, we want to investigate the effect of pneumoperitoneum, and NMB with rocuronium
      and reversal with sugammadex or neostigmine/glycopyrrolate on cerebral tissue oxygenation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Able to give written informed consent

          2. American Society of Anaesthesiologists class I, II or III

          3. Obese or morbid obese as defined by BMI > 30 and >40 kg/m2 respectively

        Exclusion Criteria:

          1. Neuromuscular disorders

          2. Allergies to, or contraindication for muscle relaxants, neuromuscular reversing
             agents, anaesthetics, narcotics

          3. Malignant hyperthermia

          4. Pregnancy or lactation

          5. Renal insufficiency defined as serum creatinine of 2x the upper normal limit,
             glomerular filtration rate < 60ml/min, urine output of < 0.5ml/kg/h for at least 6h

          6. Chronic obstructive pulmonary disease GOLD classification 2 or higher.

          7. Clinical, radiographic or laboratory findings suggesting upper or lower airway
             infection

          8. Congestive heart failure.

          9. Pickwick syndrome

         10. Psychiatric illness inhibiting cooperation with study protocol or possibly obscuring
             results