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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

Tracking Information
First Submitted Date May 21, 2019
First Posted Date June 7, 2019
Last Update Posted Date June 7, 2019
Actual Study Start Date November 2015
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 5, 2019)
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 5, 2019)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
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).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Male or female with large cerebellopontine angle tumors (>2 x 2 cm)
Condition Bradycardia
Intervention 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.

Study Groups/Cohorts Patients with large CPA tumors
Patients with large cerebellopontine angle tumors (>2 x 2cm) undergoing elective surgery
Intervention: Device: ANI
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 5, 2019)
100
Original Actual Enrollment Same as current
Actual Study Completion Date November 2017
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03978819
Other Study ID Numbers DC 2015/143
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Musa Sesay, Association de Developpement de la Neuroanesthesie Reanimation
Study Sponsor Association de Developpement de la Neuroanesthesie Reanimation
Collaborators University of Bordeaux
Investigators
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
PRS Account Association de Developpement de la Neuroanesthesie Reanimation
Verification Date June 2019