Prediction of Hemodynamic Reactivity During General Anesthesia Using Analgesia/Nociception Index (ANI)

Anesthesia Clinical Trial

Official title:

Prediction of Hemodynamic Reactivity During Desflurane/Remifentanil General Anesthesia Using Analgesia/Nociception Index (ANI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839513
• Other study ID #: CPP 2013-021B
• Status: Completed
• Phase: N/A
• First received: April 22, 2013
• Last updated: November 1, 2013
• Start date: May 2013
• Est. completion date: November 2013

Study information

• Verified date: November 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 ear-nose-throat or lower limb orthopedic surgery on desflurane/remifentanil 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: 100
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 18-75 years

• Ear-nose-throat or lower limb surgery

• General anesthesia using desflurane and remifentanil

Exclusion Criteria:

• Age <18 yrs or >75 yrs

• Arrythmia

• Preoperative use of B-blockers

• 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
Hôpital Edouard Herriot

Country where clinical trial is conducted

France, 

References & Publications (1)

Boselli E, Daniela-Ionescu M, Bégou G, Bouvet L, Dabouz R, Magnin C, Allaouchiche B. Prospective observational study of the non-invasive assessment of immediate postoperative pain using the analgesia/nociception index (ANI). Br J Anaesth. 2013 Sep;111(3):453-9. doi: 10.1093/bja/aet110. Epub 2013 Apr 16. — View Citation

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 incision, at steady-state anesthesia during procedure (an expected average of 30 min) and at arousal from general anesthesia in the end of procedure (an expected average of 60 min)	No