Clinical trial · Observational
ANI Parasympathetic Monitoring in Neurosurgery
Ability of the Analgesia Nociception Index Monitor to Distinguish Between Excessive Analgesia and Inadvertent Parasympathetic Nerve Stimulation During Surgery of Large Cerebellopontine Angle Tumours
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bradycardia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ANI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with large CPA tumors
- description
- Patients with large cerebellopontine angle tumors (\>2 x 2cm) undergoing elective surgery
- interventionNames
- Device: ANI
Primary outcomes (2)
- measure
- Differences in instantaneous ANI (ANIi) values during bradycardia versus ANIi values when Remifentanil effect size concentration >6ng/mL
- timeFrame
- ANIi values recorded at Day 1 only during surgery (duration: 4-6 hours)
- description
- 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
- measure
- Differences in the area under the ROC curves between ANI values for IPNS and EA analgesia
- timeFrame
- ANIi values recorded at Day 1 only during surgery (duration: 4-6 hours)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (9)
- BACKGROUNDRenowden 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
- BACKGROUNDSesay 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
- BACKGROUNDDe 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
- BACKGROUNDJeanne 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
- BACKGROUNDRobin 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
- BACKGROUNDKommula 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
- BACKGROUNDTheerth 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.