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OpenTrials
Completed

NCT Number: NCT04354311

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

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.

Completed

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Roger Salengro, CHU Lille

Lille, 59037, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ANI

Device

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.

Primary outcomes

  1. predictability of hemodynamic impact during laryngoscopy by tetanus-induced ANI variation,

    Time frame: 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 outcomes

  1. predictability of somatic impact during laryngoscopy by tetanus-induced ANI variation,

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: ANI_LARYNGO

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 21, 2020
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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