Prediction of Hemodynamic Response to Intubation by ANI Variation During Standardized Stimulation

Study Overview
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Brief Summary
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The objective : to investigate a correlation between ANI following a standardized nociceptive stimulus and hemodynamic or somatic reactions during orotracheal intubation. Piloted study. ANI and hemodynamic and somatic parameters response associated tetanus stimulation followed by orotracheal intubation were collected.

Detailed Description
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Background: The Analgesia Nociception Index reflects the balance between analgesia and nociception and allows early detection of a defect in analgesia. Orotracheal intubation is responsible for a sometimes deleterious hemodynamic reaction. The Analgesia Nociception Index could allow an individual adjustment of the investigator's anesthetic inductions during this period. Objective: The objective of this study is to investigate if there is a correlation between variations in the ANI following a standardized nociceptive stimulus and the occurrence of hemodynamic or somatic reactions during orotracheal intubation without muscle relaxation. Materials and Methods: Prospective, interventional, analytical, monocentric, piloted study carried out in the operating theatre after obtaining patient's informed consent between January 2014 and November 2014. Under steady state total intravenous anaesthesia with propofol and remifentanil at constant dosage (entropy between 40 and 60) tetanus stimulation of the ulnar nerve was performed followed by orotracheal intubation. The variation of ANI and hemodynamic parameters as well as the somatic response associated with both maneuvers were collected.

Official Title
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Relationship Between the ANI Score During Standardized Painful Stimulation and the Nociceptive Response to Laryngoscopy Intubation

Conditions
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Pain, Tracheal Intubation Morbidity

Intervention / Treatment
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* Device: ANI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient requiring general anaesthesia with tracheal intubation by direct laryngoscopy Intubation Difficulty Assessment Score < 7 BMI between 17 and 30 Kg/m2 Socially insured patient Patient 18 years of age or older Patient with signed consent Patient with a sinus heart rhythm Exclusion Criteria: Patient refusing to participate in the study Pregnant woman Patient with a pace maker (any mode) Patient treated with Beta Blocker Known Dysautonomia Diabetes Spontaneous ventilation anaesthesia Allergy to any of the required medications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, interventional, analytical, monocentric, piloted study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Anesthetic induction : total target-controlled intravenous anesthesia d was used with propofol and remifentanil. The effect site was then gradually increased to obtain a satisfaction depth of anesthesia. Assisted ventilation was then started by facemask ventilation (Sat O2>95% and expired CO2 fraction normal, tidal volume of 8 mL/kg, a respiratory rate of 12 cycles per minute, with an FiO2 100% with no positive end expiratory pressure. After stabilisation period of 2 minutes and record of the patient's parameters, a standardized nociceptive stimulation was applied at the level of the ulnar nerve (PTC of 50 Hz at 70 mA). The variation of ANI score and hemodynamic parameters were collected during the 2 following minutes. After stabilization of ANI, orotracheal intubation was attempted. Maximal variation of heart rate (HR), blood pressure and the occurrence of somatic manifestations (intense cough, movement, tears) were recorded. | Device: ANI<br>* Under steady state total intravenous anaesthesia with propofol and remifentanil at constant dosage, tetanus stimulation of the ulnar nerve was performed followed by orotracheal intubation. The variation of ANI and hemodynamic parameters as well as the somatic response associated with both maneuvers were collected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| predictability of hemodynamic impact during laryngoscopy by tetanus-induced ANI variation, | area under the corresponding Receiver Operating Characteristic curve with DeltaTetanus as dependent variable, and Hemodynamic Impact as state variable | measurement during intubation, an average 40 seconds and 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| predictability of somatic impact during laryngoscopy by tetanus-induced ANI variation, | area under the corresponding Receiver Operating Characteristic curve with DeltaTetanus as dependent variable, and Somatic Impact as state | observation during intubation, an average between 40 seconds and 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ANI, hemodynamic responses, tracheal intubation