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ANI Parasympathetic Monitoring in Neurosurgery (ANI)

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ClinicalTrials.gov Identifier: NCT03978819
Recruitment Status : Completed
First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Sponsor:
Collaborator:
University of Bordeaux
Information provided by (Responsible Party):
Musa Sesay, Association de Developpement de la Neuroanesthesie Reanimation

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.


Condition or disease Intervention/treatment
Bradycardia Device: ANI

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).


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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : November 2015
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with large CPA tumors
Patients with large cerebellopontine angle tumors (>2 x 2cm) undergoing elective surgery
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.





Primary Outcome Measures :
  1. Differences in instantaneous ANI (ANIi) values during bradycardia versus ANIi values when Remifentanil effect size concentration >6ng/mL [ Time Frame: ANIi values recorded at Day 1 only during surgery (duration: 4-6 hours) ]
    ANI, HR and Remifentanil effect site concentration were continuously recorded with event markers on the ANI monitor at the onset of bradycardia (HR<45 bpm) or Remifentanil effect site concentration>6ng/mL

  2. Differences in the area under the ROC curves between ANI values for IPNS and EA analgesia [ Time Frame: ANIi values recorded at Day 1 only during surgery (duration: 4-6 hours) ]
    ROC curves were built at different ANIi for IPNS or EA


Secondary Outcome Measures :
  1. Percentages of IPNS and EA cases [ Time Frame: Cases observed at Day 1 only during surgery (duration: 4-6 hours) ]
    The percentages of IPNS or EA cases on the overall study population were calculated.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male or female with large cerebellopontine angle tumors (>2 x 2 cm)
Criteria

Inclusion Criteria:

  • patients undergoing elective surgery of large cerebellopontine angle tumors

Exclusion Criteria:

  • age below 18yr
  • arrhythmia
  • preoperative use of vagolytics, β-blockers and clonidine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03978819


Locations
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France
CHU Bordeaux University Hospital
Bordeaux, France, 33076
Sponsors and Collaborators
Association de Developpement de la Neuroanesthesie Reanimation
University of Bordeaux
Investigators
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Principal Investigator: Musa Sesay, M.D ADNR, Neuroanesthesia and Critical Care, 33076 Bordeaux, France
Study Director: Matthieu Biais, M.D., PhD Neuroanesthesia and Critical Care, CHU University Bordeaux
Study Chair: Karine Nouette-Gaulain, M.D., Ph.D Neuroanesthesia and Critical Care, CHU University Bordeaux
  Study Documents (Full-Text)

Documents provided by Musa Sesay, Association de Developpement de la Neuroanesthesie Reanimation:

Publications:
Robin F, Sesay M, Kolanek B, Pena D, Penna M, Morel-Locket L et al. The analgesia nociception index monitor (ANI) can detect indvertent vagal stimulation during surgery of cerebello-pontine angle tumors. Br J Anaesth 2013;111: https: // doi.org/10.1093/bja/el_10195

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Responsible Party: Musa Sesay, Principal Investigator, Association de Developpement de la Neuroanesthesie Reanimation
ClinicalTrials.gov Identifier: NCT03978819     History of Changes
Other Study ID Numbers: DC 2015/143
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Musa Sesay, Association de Developpement de la Neuroanesthesie Reanimation:
Analgesia nociception index
Parasympathetic nerve stimulation
Excessive analgesia
Additional relevant MeSH terms:
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Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes