Reversal of Neuromuscular Blockade and Perioperative Arrhythmias

• Status: Completed
• Trial end date: 2019-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Basaksehir Cam & Sakura Şehir Hospital
• Collaborator: Medipol University
• Treatments: Neostigmine

Criteria

Inclusion Criteria:

• Planned abdominopelvic surgery under general anesthesia

• ASA II-IV

• Willing to give consent

Exclusion Criteria:

• Significantly impaired left ventricular systolic function (ejection fraction < 40%)

• Significant ongoing arrhythmia (sinus bradycardia with a heart rate below 40 beats/min, Mobitz Type II or 3rd-grade atrioventricular block, persistent or permanent atrial flutter or fibrillation, bigeminal or trigeminal ventricular premature beats, documented ventricular tachycardia)

• Severely reduced renal function (glomerular filtration rate < 30 ml/min/1.73 m2)

• Severe respiratory diseases, neuromuscular disorders, and known allergy to anesthetic agents or adjuvants

• Pregnancy and breastfeeding

• Observing the typical signs of a channelopathy (short QT syndrome, long QT syndrome, Brugada syndrome, etc.) and history of recent medical therapy with agents exhibiting a high probability of QT prolongation