Sugammadex and Neostigmine at Shallow Neuromuscular Blockade
Condition: Neuromuscular Block
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to compare recovery times after reversal of a residual neuromuscular
      block (TOF-ratio 0.5) with different doses of either neostigmine or sugammadex.
    

Detailed description: 
      Muscle relaxants are integral part of modern anesthesia. They optimize intubating conditions,
      reduce laryngeal trauma and improve operating conditions. Drawback is a possible
      pharmacological (muscle relaxing) effect of these drugs beyond the end of the operation (i.e.
      post-operative residual curarization: PORC). Reportedly about 30% of all patients who
      received muscle relaxants show signs of PORC when arriving in the post-anesthesia care unit.
      PORC comprises the risk of impaired post-operative fine motor and coordinative skills with a
      possible impairment of swallowing pharyngeal secretions with an increased risk of aspiration
      after extubation. Possible deleterious effects of this could be pneumonia, bronchitis,
      myocardial infarction, cardiac insufficiency, stroke or re-operation.

      In order to avoid PORC patients with residual neuromuscular block receive a muscle relaxant
      antagonist from the anesthetist at the end of the operation. However, these drugs
      (neostigmine, pyridostigmine, etc.) from the class of cholinesterase inhibitors have unwanted
      effects such as bradycardia, increased gastro-intestinal motility, post-operative nausea and
      vomiting, salivation etc. To decrease these unwanted side effects cholinesterase inhibitors
      have to be given in combination with parasympatholyics e.g. atropine or glycopyrrolate with
      their own spectrum of unwanted side effects.

      From October 2008 on, Sugammadex, a completely new reversal drug was introduced in to
      clinical practice. Sugammadex, is a modified gamma-cyclodextrine able to specifically bind
      rocuronium (a steroidal muscle relaxant). The complex is eliminated via the kidneys. However,
      all studies so far have focussed on reversal of profound or deep neuromuscular blockade. This
      study is designed to compare recovery times after reversal of a residual neuromuscular block
      (TOF-ratio 0.5) with different doses of either the neostigmine or sugammadex.
    

Intervention name(s): Sugammadex, Neostigmine, Saline
Intervention type(s): Drug
Intervention description(s): Single intravenous injection of either:
Sugammadex 0.0625 mg/kg (Sgx 0.0625) Sugammadex 0.125 mg/kg (Sgx 0.125) Sugammadex 0.25 mg/kg (Sgx 0.25) Sugammadex 0.5 mg/kg (Sgx 0.5) Sugammadex 1.0 mg/kg (Sgx 1.0) Neostigmine 5 mg/kg (Neo 5) Neostigmine 8 mg/kg (Neo 8) Neostigmine 15 mg/kg (Neo 15) Neostigmine 25 mg/kg (Neo 25) Neostigmine 40 mg/kg (Neo 40) Saline 0.9% (Saline)
Intervention MeSH terms: Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Residual neuromuscular block; post-operative residual curarization; PORC; sugammadex; neostigmine; Shallow neuromuscular block (TOF-ratio of 0.5)