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ANI Parasympathetic Monitoring in Neurosurgery (ANI)
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 |
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 |
| 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 |
| 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. |
- 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
- 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.
| 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 |
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.
| France | |
| CHU Bordeaux University Hospital | |
| Bordeaux, France, 33076 | |
| 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 |
| 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 |
|
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| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | No Changes Posted | |||||||||
| Current Secondary Outcome Measures |
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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| 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. |
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| 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 | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| 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. |
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| Study Groups/Cohorts | Patients with large CPA tumors
Patients with large cerebellopontine angle tumors (>2 x 2cm) undergoing elective surgery
Intervention: Device: ANI
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Completed | |||||||||
| Actual Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| 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 |
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| IPD Sharing Statement |
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| 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 |
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| PRS Account | Association de Developpement de la Neuroanesthesie Reanimation | |||||||||
| Verification Date | June 2019 | |||||||||
