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Value of the Analgesia Nociception Index (ANI) to intraoperatively predict changes in blood pressure and heart rate

Intraoperative patients: value of the Analgesia Nociception Index to predict changes in heart rate and blood pressure.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12613000212752
Acronym
ANI2
Enrollment
30
Registered
2013-02-22
Start date
2012-12-19
Completion date
2013-02-15
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The Analgesia nociception index (ANI) is a novel score aiming to enable anaesthetists to estimate pain perception in anaesthetized patients. It work via 2 sticky (single use) electrodes applied to the chest (like ECG electrodes) from which it derives ECG data. This is then transformed into an index from 0-100, the ANI which will be larger in states of comfort and smaller in states of more pain. Although non-invasive and risk free, very few data exist to show the association of ANI with standard measures of nociception/pain in unconscious subjects: changes in blood pressure, heart rate or patient movement. We aim to do an observational trial on 30 patients in which we attach ANI monitoring to anaesthetized patients, record the ANI score continuously and match these records with other patient data obtained at the same time (blood pressure, heart rate, patient movement). This should enable us to get a better idea about the predictive value of ANI changes to preempt changes in above mentioned standart observations.

Interventions

Observation (continuous monitoring) of the analgesia nociception index (ANI) during anaesthesia for elective surgery. Simulataneously monitoring of systolic blood pressure, heart rate and bispectral index. ANI will be monitored over the entire period of anaesthesia (hence varying times between patients) by means of 2 sticky electrodes applied to the patient's chest. The sampled electrogrardiographic data is then used to calculate cardiac poarasympathetic activity, and finally displayed as a 0-10

Observation (continuous monitoring) of the analgesia nociception index (ANI) during anaesthesia for elective surgery. Simulataneously monitoring of systolic blood pressure, heart rate and bispectral index. ANI will be monitored over the entire period of anaesthesia (hence varying times between patients) by means of 2 sticky electrodes applied to the patient's chest. The sampled electrogrardiographic data is then used to calculate cardiac poarasympathetic activity, and finally displayed as a 0-100 score (high numbers mean more comfortable patient).

Sponsors

Thomas Ledowski
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients scheduled for non-emergency surgery planned to be anaesthetized using sevoflurane and fentanyl.

Exclusion criteria

Patients on medication with beta-receptorblockers, clonidine, ketamine, continuous infusion of vasoactive substances, neostigmine, glycopyrrolate or atropine. Patients with incapacity to consent, < 18 years or patients who not wish to participate. Patients with an allergy to sticky ecg electrodes as well as patients with a pacemaker. Patients whose surgery will include use of a tourniquet will also be excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026