Residual Paralysis and Reversal With Routine Neostigmine Versus Half-dose Sugammadex and Routine Neostigmine
Condition: Neuromuscular Blockade; Sugammadex; Neostigmine; Complication of Anesthesia; Postoperative Residual Curarization; Rocuronium
MeSH terms: Delayed Emergence from Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      Sugammadex may prevent residual neuromuscular blockade by providing rapid reversal at the end
      of the operation. Our goal is to compare the half-dose use of sugammadex for reversing
      residual blockade after administration of neostigmine and atropine to the routine use of
      reversal medication.
    

Detailed description: 
      Background: Postoperative residual neuromuscular block (PONB) may be observed in patients in
      the recovery room after surgery, and this event causes significant adverse events such as
      respiratory muscle weakness, decreased tidal volumes causing hypoxemia, reintubation,
      prolonged mechanical ventilation, and possible risk for a cardiopulmonary arrest.

      Goal: The study investigators hypothesized to investigate the effects of the half-dose use of
      sugammadex for reversing residual blockade after administration of neostigmine and atropine
      and compare these results to the routine full-dose use neostigmine and atropine.

      The Study Design:

      The study investigators planned to perform a prospective, single-blinded, randomized trial.

      The study Protocol:

      The investigators enrolled patients undergoing lower abdominal tumor resection surgery under
      general anesthesia who fulfill our inclusion criteria.

      The study is single-blinded because the anesthesia resident, anesthesia technician, and
      anesthesia personnel, including the data collector, were blinded to the randomization. The
      supervising anesthesiologist was also a data collector, and she was not blinded to the study
      protocol.

      The randomization into two groups required the use of a computer system. The study
      investigators performed a random allocation sequence by the use of randomized block design
      codes that are generated from a computer. Afterward, the study investigators opened an opaque
      and sealed envelope that contained the generated codes and randomly divided patients into two
      groups. During this process, they made sure that all study personnel was blinded to the
      randomization.

      The study investigators divide patients into two groups after the randomization process, and
      the groups are as follows: The first group of 48 patients is called Group N. In this group of
      patients, and we administer intravenous neostigmine 0.05 mg/kg and atropine 0.02 mg/kg in a
      single syringe before extubation. The second group of 50 patients is called Group N+S. In
      Group N+S, the study investigators administered the standard reversal medications of
      intravenous neostigmine 0.05 mg/kg and atropine 0.02 mg/kg. Three minutes later, the study
      'investigators administered an intravenous bolus dose of 1 mg/kg sugammadex in a different
      syringe prepared earlier as a reversal agent.

      The Study Measurement of Parameters. The patients require general anesthesia induction with
      an intermediate-acting neuromuscular blocking age, rocuronium, at a dose of 0.06 mg/kg
      intravenously.

      After induction of anesthesia and before administration of rocuronium, the investigators
      monitored train-of-four (TOF) counts using a monitoring device of neuromuscular blockade at
      the patient's ulnar nerve. For this purpose, they placed two surface electrodes above the
      ulnar nerve near the wrist. To monitor the nerve stimuli at the adductor pollicis muscle
      using acceleromyography (TOF Watch SX, Schering-Plough Ireland, Dublin, Ireland). After
      induction of general anesthesia, the TOF Watch device provided 50-Hz tetanic stimulation for
      5 seconds, and one minute after this tetanic stimulation, it offered a train-of-four (TOF)
      stimulation. Depending on the TOF-watch-related parameters, they decided to administer
      rocuronium, the neuromuscular agent, or not. At the end of the surgery, all anesthetics
      needed to be discontinued, including inhalational agents who were sevoflurane and nitrous
      oxide. Once the end-tidal concentration of sevoflurane reached a 0.4-0.6% level, the
      investigators administered the previously randomized reversal study drug.

      For the administration of the reversal agents, there was a need for a TOF count of 2 observed
      in the TOF Watch device. A TOF count of 2 in TOF Watch monitoring provided information of a
      shallow neuromuscular block.

      The Collected Parameters. They observed the clinical signs of recovery using several
      parameters. These parameters are level of consciousness, head-lift test, ability to sustain
      head lift, general muscle weakness, laryngospasm, and desaturation.

      The study investigators collected the periods between the last dose of intravenous rocuronium
      and administering a reversal agent, administering a reversal agent to extubation, and
      administering a reversal agent to operating room discharge. These periods were in minutes.
      They also collected the recovery periods between the start of helping reversal agent to the
      recovery of TOF ratio < 0.9 to 0.7 and TOF ratio ≥ 0.9, which were in minutes.

      They collected hemodynamical data, including; noninvasive mean arterial pressure, heart rate
      measurements, and peripheral oxygen saturation values before and subsequently at 2, 5, 10,
      and 30 minutes after administering the reversal drugs and in the recovery room.

      The primary outcome was the incidence of a train-of-four (TOF) ratio less than 0.9 at
      tracheal extubation. The secondary outcomes were periods between the start of administering
      reversal agents and extubation or operating room discharge in minutes to achieve recovery of
      TOF ratio < 0.9 to 0.7 and TOF ratio ≥ 0.9.
    

Intervention name(s): Neostigmine; Sugammadex
Intervention type(s): Drug; Drug
Intervention description(s): The study investigators administer neostigmine at the end of operation to reverse neuromuscular blockade, and the routine dose of the intravenous neostigmine is 0.05 mg/kg and atropine 0.02 mg/kg. The dose is given in a single syringe, and later they administer this reversal medication before extubation.
In the case of a residual block, the neostigmine group of patients receives a rescue dose of neostigmine at a dose of 0.03 mg/kg in the operating room fifteen minutes before discharge.; The study investigators administer the routine full-dose neostigmine reversal medication and three minutes later, they administer an intravenous bolus dose of 1 mg/kg sugammadex in a different syringe prepared earlier as a reversal agent. The anesthesia team considers using an intravenous rescue dose of 1 mg/kg sugammadex for this group of patients in the recovery room if patients do not show a complete recovery of TOF ratio equal to >0.9 in the recovery room before discharge to the ward.
Other intervention name(s): Routine full-dose reversal medication; Routine full-dose reversal medication and half-dose sugammadex
Intervention MeSH terms: Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized prospective clinical trial
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Residual Curarization; Postoperative; Complication; Neuromuscular blockade; Neostigmine; Sugammadex; Rocuronium