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ANI Parasympathetic Monitoring in Neurosurgery

NCT03978819 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2019-06-07

No results posted yet for this study

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.

Conditions

  • Bradycardia

Interventions

DEVICE

ANI

ANI profiles during IPNS (bradycardia/asystole) or excessive analgesia. During surgery continuous monitoring of ANI, HR and Remifentanil effect site concentration was done and recorded. Event markers were placed at the onset of bradycardia, asystole and the coincidence of ANI\>80 + Remifentanil \>6ng/mL). ANI values of 1 min before and 1 min after the event were used for analysis.

Sponsors & Collaborators

  • University of Bordeaux

    collaborator OTHER

  • Association de Developpement de la Neuroanesthesie Reanimation

    lead OTHER

Principal Investigators

  • Musa Sesay, M.D · ADNR, Neuroanesthesia and Critical Care, 33076 Bordeaux, France

  • Matthieu Biais, M.D., PhD · Neuroanesthesia and Critical Care, CHU University Bordeaux

  • Karine Nouette-Gaulain, M.D., Ph.D · Neuroanesthesia and Critical Care, CHU University Bordeaux

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03978819 on ClinicalTrials.gov