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Spots Global Cancer Trial Database for ANI Parasympathetic Monitoring in Neurosurgery

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Trial Identification

Brief Title: ANI Parasympathetic Monitoring in Neurosurgery

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

Study ID: NCT03978819

Conditions

Bradycardia

Interventions

ANI

Study Description

Brief Summary: 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.

Detailed Description: 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).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

CHU Bordeaux University Hospital, Bordeaux, , France

Contact Details

Name: Musa Sesay, M.D

Affiliation: ADNR, Neuroanesthesia and Critical Care, 33076 Bordeaux, France

Role: PRINCIPAL_INVESTIGATOR

Name: Matthieu Biais, M.D., PhD

Affiliation: Neuroanesthesia and Critical Care, CHU University Bordeaux

Role: STUDY_DIRECTOR

Name: Karine Nouette-Gaulain, M.D., Ph.D

Affiliation: Neuroanesthesia and Critical Care, CHU University Bordeaux

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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