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

Pain Clinical Trial

— ANI_LARYNGO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04354311
• Other study ID #: 2012_34
• Secondary ID: 2013-A01127-38
• Status: Completed
• Phase: N/A
• Start date: February 2, 2014
• Est. completion date: December 2014

Study information

• Verified date: April 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Tracheal Intubation Morbidity

Intervention

Device:
• ANI
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.

Locations

Country	Name	City	State
France	Hopital Roger Salengro, CHU Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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