ANI Parasympathetic Monitoring in Neurosurgery

NCT03978819 | Completed

• 1 other identifier: DC 2015/143
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Bradycardia

Keywords

Analgesia nociception index; Parasympathetic nerve stimulation; Excessive analgesia

Outcome Measures

Primary Outcomes (2)

• Differences in instantaneous ANI (ANIi) values during bradycardia versus ANIi values when Remifentanil effect size concentration >6ng/mL

  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

  ANIi values recorded at Day 1 only during surgery (duration: 4-6 hours)

• Differences in the area under the ROC curves between ANI values for IPNS and EA analgesia

  ROC curves were built at different ANIi for IPNS or EA

  ANIi values recorded at Day 1 only during surgery (duration: 4-6 hours)

Secondary Outcomes (1)

• Percentages of IPNS and EA cases

  Cases observed at Day 1 only during surgery (duration: 4-6 hours)

Study Arms (1)

Patients with large CPA tumors

Patients with large cerebellopontine angle tumors (\>2 x 2cm) undergoing elective surgery

Device: ANI

Interventions

ANI DEVICE

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.

Patients with large CPA tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male or female with large cerebellopontine angle tumors (\>2 x 2 cm)

You may qualify if:

• patients undergoing elective surgery of large cerebellopontine angle tumors

You may not qualify if:

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

Sponsors & Collaborators

• Association de Developpement de la Neuroanesthesie Reanimation: lead
• University of Bordeaux: collaborator

Study Sites (1)

CHU Bordeaux University Hospital

Bordeaux, 33076, France

Location

Related Publications (9)

• Renowden S. Imaging of the cerebello-pontine angle. Pract Neurol. 2014 Oct;14(5):e2. doi: 10.1136/practneurol-2014-000949. Epub 2014 Aug 12. No abstract available.

  PMID: 25118279 BACKGROUND

• Sesay M, Vignes JR, Stockle M, Mehsen M, Boulard G, Maurette P. [Spectral analysis of the ECG R-R interval permits early detection of vagal responses to neurosurgical stimuli]. Ann Fr Anesth Reanim. 2003 May;22(5):421-4. doi: 10.1016/s0750-7658(03)00094-7. French.

  PMID: 12831969 BACKGROUND

• De Jonckheere J, Rommel D, Nandrino JL, Jeanne M, Logier R. Heart rate variability analysis as an index of emotion regulation processes: interest of the Analgesia Nociception Index (ANI). Annu Int Conf IEEE Eng Med Biol Soc. 2012;2012:3432-5. doi: 10.1109/EMBC.2012.6346703.

  PMID: 23366664 BACKGROUND

• Jeanne M, Clement C, De Jonckheere J, Logier R, Tavernier B. Variations of the analgesia nociception index during general anaesthesia for laparoscopic abdominal surgery. J Clin Monit Comput. 2012 Aug;26(4):289-94. doi: 10.1007/s10877-012-9354-0. Epub 2012 Mar 28.

  PMID: 22454275 BACKGROUND

• 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

  BACKGROUND

• Kommula LK, Bansal S, Umamaheswara Rao GS. Analgesia Nociception Index Monitoring During Supratentorial Craniotomy. J Neurosurg Anesthesiol. 2019 Jan;31(1):57-61. doi: 10.1097/ANA.0000000000000464.

  PMID: 28991059 BACKGROUND

• Theerth KA, Sriganesh K, Reddy KM, Chakrabarti D, Umamaheswara Rao GS. Analgesia Nociception Index-guided intraoperative fentanyl consumption and postoperative analgesia in patients receiving scalp block versus incision-site infiltration for craniotomy. Minerva Anestesiol. 2018 Dec;84(12):1361-1368. doi: 10.23736/S0375-9393.18.12837-9. Epub 2018 Jul 9.

  PMID: 29991223 BACKGROUND

• Fletcher D, Martinez V. Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis. Br J Anaesth. 2014 Jun;112(6):991-1004. doi: 10.1093/bja/aeu137.

  PMID: 24829420 BACKGROUND

• Galley HF. Editorial II: Solid as a ROC. Br J Anaesth. 2004 Nov;93(5):623-6. doi: 10.1093/bja/aeh247. No abstract available.

  PMID: 15472141 BACKGROUND

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Musa Sesay, M.D

  ADNR, Neuroanesthesia and Critical Care, 33076 Bordeaux, France

  PRINCIPAL INVESTIGATOR

• Matthieu Biais, M.D., PhD

  Neuroanesthesia and Critical Care, CHU University Bordeaux

  STUDY DIRECTOR

• Karine Nouette-Gaulain, M.D., Ph.D

  Neuroanesthesia and Critical Care, CHU University Bordeaux

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: June 7, 2019
• Study Start: November 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: June 7, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)