Reversal of Neuromuscular Blockade and Perioperative Arrhythmias
Condition: Neuromuscular Blockade
MeSH terms: Arrhythmias, Cardiac
Study type: Interventional

Summary: 
      Patients scheduled for elective abdominopelvic laparoscopic surgery under general anesthesia
      were included. Rocuronium was used for the neuromuscular blockade (NMB) and the level of NMB
      was monitored with train-of-four (TOF) measurements. The participants from whom informed
      consent had been received were allocated to two groups according to the agent used for
      reversal of NMB, sugammadex, or neostigmine. The ECG recordings of the subjects were followed
      with a rhythm Holter device throughout the procedure until the postoperative 12th hour.
      Additionally, preoperative and immediate postoperative 12-lead ECGs were evaluated for
      corrected QT calculations and QT dispersion. Proarrhythmogenicity was assessed with QT
      related measurements. The documented arrhythmic events on the Holter monitoring were
      designated as clinical end-points.
    

Detailed description: 
      Eighty consecutive patients, to whom an elective abdominopelvic surgery under general
      anesthesia was planned, were included in the study. Participants were allocated to two groups
      considering the agent to be used for the reversal of neuromuscular blockade by
      closed-envelope randomization. Neostigmine was used for this purpose in Group N, while
      sugammadex was used in Group S. Demographic features including hypertension, diabetes
      mellitus, presence of coronary artery disease, heart failure, and previous arrhythmia were
      noted. Body mass index was calculated with the Du Bois method. In the operation room, heart
      rate, blood pressure, body temperature, arterial oxygen saturation, and TOF ratio were
      recorded. General anesthesia was induced with midazolam, fentanyl, and propofol; and
      maintained by remifentanil and sevoflurane. In Group N, 50 mcg/kg neostigmine and 20 mcg/kg
      atropine were used for NMB reversal. In Group S, reversal was achieved by the administration
      of sugammadex at a dose of 2 mg/kg. QT interval was measured in leads DII or V5 and adjusted
      to the heart rate by the Bazzett formula. QTc values at the baseline and postoperative ECGs
      were recorded and presented with milliseconds. An increase of over 60 ms in QTc interval or a
      postoperative measurement over 500 ms were assumed to be distinctly abnormal. QT dispersion
      was calculated by extracting the minimum QT length from the maximum QT length in 12-lead ECG.
      In rhythm holter monitoring, minimum and mean heart rates and specific arrhythmic events were
      recorded. In the heart rate variability analysis, the standard deviation of the interbeat
      intervals of normal sinus beats (SDNN) and the root mean square of successive differences
      between normal heartbeats (rMSSD) were calculated. The following events were designated as
      clinical end-points.

        -  Pause (no waves on ECG recording at least for 3 seconds)

        -  Significant bradycardia (sinus bradycardia persisted at least for 30 seconds with a rate
           below 50 beats/min)

        -  High-grade atrioventricular block (2nd-degree Mobitz Type II or 3rd degree)

        -  Supraventricular tachycardia (sudden onset tachycardia with narrow QRS complexes
           persisted over 30 seconds)

        -  Atrial flutter or fibrillation (sustained over 30 seconds)

        -  Frequent premature ventricular beats (≥30 beats/hour)

        -  Any ventricular tachycardia (wide QRS complexes)
    

Intervention name(s): Neostigmine; Sugammadex
Intervention type(s): Drug; Drug
Intervention description(s): 50 mcg/kg neostigmine was used under the guidance of TOF monitoring after cessation of anesthesia.; 2 mg/kg sugammadex was used under the guidance of TOF monitoring after cessation of anesthesia.
Intervention MeSH terms: Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1 randomization
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Bradycardia; Cardiac Arrhythmias; Neostigmine; Neuromuscular Blockade; Sugammadex; Train-of-Four Monitoring