Clinical trial NCT04354311: Prediction of Hemodynamic Response to Intubation by ANI Variation During Standardized Stimulation
Official title: Relationship Between the ANI Score During Standardized Painful Stimulation and the Nociceptive Response to Laryngoscopy Intubation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheal Intubation Morbidity
Pain
Keywords: ANI
hemodynamic responses
tracheal intubation
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, interventional, analytical, monocentric, piloted study
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: predictability of hemodynamic impact during laryngoscopy by tetanus-induced ANI variation,
timeFrame: measurement during intubation, an average 40 seconds and 5 minutes
Secondary outcomes:
measure: predictability of somatic impact during laryngoscopy by tetanus-induced ANI variation,
timeFrame: observation during intubation, an average between 40 seconds and 5 minutes
Other outcomes:
Locations:
city: Lille
country: France
facility: Hopital Roger Salengro, CHU Lille
Study officials:
affiliation: University Hospital, Lille
name: Elsa Jozefowicz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jozefowicz E, Sabourdin N, Fontaine V, Lambelin V, Lejeune V, Menu H, Bourai M, Tavernier B. Prediction of reactivity during tracheal intubation by pre-laryngoscopy tetanus-induced ANI variation. J Clin Monit Comput. 2022 Feb;36(1):93-101. doi: 10.1007/s10877-020-00624-6. Epub 2021 Jan 2.