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

Not Applicable

Completed

• Conditions: Pain; Tracheal Intubation Morbidity
• Interventions: Device: ANI

• Registration Number: NCT04354311
• Lead Sponsor: University Hospital, Lille

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.

Study Timeline

• Study Start: 2014-02-02
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2020-04
• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-20
• Last Update Submitted: 2020-04-20
• Study First Posted: 2020-04-21
• Last Update Posted: 2020-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	ANI	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hopital Roger Salengro, CHU Lille; 🇫🇷 Lille, France