CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
ANIdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03978819
NCT03978819N/ACompleted

Ability of the Analgesia Nociception Index Monitor to Distinguish Between Excessive Analgesia and Inadvertent Parasympathetic Nerve Stimulation During Surgery of Large Cerebellopontine Angle Tumours

Association de Developpement de la Neuroanesthesie Reanimation·observational·Posted Jun 7, 2019·Updated Jun 7, 2019

In Brief

An observational study evaluating ANI for Bradycardia. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBradycardia
CountriesFrance

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 7, 2019
Enrollment StartNov 1, 2015
Primary CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 7.1 years ago

Interventions

ANIdevice

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.