Prediction of Hemodynamic Reactivity During Suspension Laryngoscopy Using Analgesia/Nociception Index (ANI)

Anesthesia Clinical Trial

Official title:

Prediction of Hemodynamic Reactivity During Suspension Laryngoscopy Using Analgesia/Nociception Index (ANI): an Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01796210
• Other study ID #: CPP 2012-046B
• Status: Completed
• Phase: N/A
• First received: February 18, 2013
• Last updated: June 6, 2013
• Start date: October 2012
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• Source: Hôpital Edouard Herriot
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial Summary

The aim of this study is to evaluate the performance of Analgesia/Nociception Index for the prediction of hemodynamic reactivity in adult patients undergoing suspension laryngoscopy on general anesthesia.

Description:

Measurement of analgesia/nociception index at different time points during procedure and assessment of analgesia/nociception index to predict hemodynamic reactivity by building receiver observer's characteristic curve.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 18-75 years

• Suspension laryngoscopy for diagnostic or therapeutic purposes

• Total intravenous anesthesia using propofol and remifentanil

Exclusion Criteria:

• age <18 yrs or >75 yrs

• arrythmia

• administration of anticholinergic drugs or neuromuscular blockade reversal in the 20 previous minutes

• psychiatric diseases

• autonomic nervous system disorders (epilepsy)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia

Locations

Country	Name	City	State
France	Hôpital Édouard Herriot, HCL	Lyon	Rhône

Sponsors (1)

Lead Sponsor	Collaborator
Emmanuel Boselli

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in heart rate and/or systolic blood pressure by more than 20% within 5 minutes		Before induction of anesthesia, 1 min after beginning of procedure, at steady-state anesthesia during procedure (an expected average of 10 min) and at arousal from general anesthesia in the end of procedure (an expected average of 20 min)	No