Bradycardia Clinical Trial
Official title:
Ability of the Analgesia Nociception Index Monitor to Distinguish Between Excessive Analgesia and Inadvertent Parasympathetic Nerve Stimulation During Surgery of Large Cerebellopontine Angle Tumours
Surgery of large cerebellopontine angle (CPA) tumors (>2 x 2 cm diameter), with compression
of the pons exposes the patient to inadvertent parasympathetic nerve stimulation (IPNS)
leading to bradycardia and asystole.
The analgesia nociception index (ANI) monitor assesses the balance between analgesia and
nociception through the detection of parasympathetic tone. ANI >80 generally denotes
excessive analgesia (EA). The main objective of this study was to determine whether ANI
values for IPNS are different or the same as ANI values for EA. This study also aims at
calculating the number of patients with IPNS and EA during surgery of large CPA tumours.
Bradycardia and asystole are potential life threatning complications during surgery of large
cerebellopontine angle (CPA) tumors (>2 x 2 cm diameter), with compression of the pons.The
incidence of such complications are unknown. One of the plausible mechanisms is inadvertent
parasympathetic nerve stimulation (IPNS) due to the proximity of this cranial nerve to the
CPA tumor. Monitoring parasympathetic nerve activity may provide further insight to the
implication of this cranial nerve in the cardiac complications observed during surgery of
large CPA tumors. The analgesia nociception index (ANI) monitor assesses the balance between
analgesia and nociception through the detection of parasympathetic tone. Despite the abundant
clinical reports about this index, to the knowledge of the investigators, only a few studies
have been published in the neurological setting. Moreover, there are no data reporting the
parasympathetic profile (measured by the ANI monitor) in situations of IPNS and EA. Are these
profiles the same or different? Such is the main question this study thrives to answer.
Understanding the behavior of parasympathetic nerve activity in this context could help
provide the appropriate management strategy.
In order to answer this question, participants undergoing elective large CPA tumor surgery
were included in this prospective observational study. Standard cardiorespiratory monitoring
including heart rate (HR) was done. Target-controlled anesthesia with Propofol and
Remifentanil was guided by a bispectral index of 30-40 and an ANI of 50-70 respectively. Data
was continuously recorded with event markers at the onset of bradycardia (HR < 45 bpm),
asystole and the coincidence of ANI > 80 with Remifentanil site effect > 6 ng.ml-1 (defined
as excessive analgesia).
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