Pain, Tracheal Intubation Morbidity
Conditions
Keywords
ANI, hemodynamic responses, tracheal intubation
Brief summary
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
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.
Interventions
DEVICEANI
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.
Sponsors
University Hospital, Lille
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Patients under general anesthesia during the procedure
Intervention model description
Prospective, interventional, analytical, monocentric, piloted study
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| predictability of hemodynamic impact during laryngoscopy by tetanus-induced ANI variation, | measurement during intubation, an average 40 seconds and 5 minutes | area under the corresponding Receiver Operating Characteristic curve with DeltaTetanus as dependent variable, and Hemodynamic Impact as state variable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| predictability of somatic impact during laryngoscopy by tetanus-induced ANI variation, | observation during intubation, an average between 40 seconds and 5 minutes | area under the corresponding Receiver Operating Characteristic curve with DeltaTetanus as dependent variable, and Somatic Impact as state |
Countries
France
Outcome results
None listed