Study Results
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Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2015-11-30
2017-11-30
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with large CPA tumors
Patients with large cerebellopontine angle tumors (\>2 x 2cm) undergoing elective surgery
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* arrhythmia
* preoperative use of vagolytics, β-blockers and clonidine.
18 Years
ALL
No
Sponsors
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University of Bordeaux
OTHER
Association de Developpement de la Neuroanesthesie Reanimation
OTHER
Responsible Party
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Musa Sesay
Principal Investigator
Principal Investigators
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Musa Sesay, M.D
Role: PRINCIPAL_INVESTIGATOR
ADNR, Neuroanesthesia and Critical Care, 33076 Bordeaux, France
Matthieu Biais, M.D., PhD
Role: STUDY_DIRECTOR
Neuroanesthesia and Critical Care, CHU University Bordeaux
Karine Nouette-Gaulain, M.D., Ph.D
Role: STUDY_CHAIR
Neuroanesthesia and Critical Care, CHU University Bordeaux
Locations
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CHU Bordeaux University Hospital
Bordeaux, , France
Countries
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References
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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.
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.
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.
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.
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
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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DC 2015/143
Identifier Type: -
Identifier Source: org_study_id
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