Clinical Trials Directory

Trials / Completed

CompletedNCT04354311

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
University Hospital, Lille · Academic / Other
Sex
All
Age
18 Years – 99 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEANIUnder 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.

Timeline

Start date
2014-02-02
Primary completion
2014-12-01
Completion
2014-12-01
First posted
2020-04-21
Last updated
2025-12-22

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04354311. Inclusion in this directory is not an endorsement.