Evaluation of Analgesia Nociception Index (ANI) During Propofol/Remifentanil and Sevoflurane/Remifentanil Anesthesia

General Anaesthesia Clinical Trial

Official title:

Detection of Nociceptive Stimulation by Analgesia Nociception Index (ANI) During Anesthesia With Propofol or Sevoflurane and Varying Remifentanil Concentrations.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01522508
• Other study ID #: ANI-134-1
• Status: Recruiting
• Phase: N/A
• First received: January 26, 2012
• Last updated: June 14, 2012
• Start date: June 2011
• Est. completion date: October 2012

Study information

• Verified date: June 2012
• Source: University of Schleswig-Holstein
• Contact: Matthias Gruenewald, MD
• Phone: +49 431 597 2991
• Email: matthias.gruenewald[@]uksh.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

The aim of this prospective randomized study was to evaluate the ability of the new Analgesia Nociception Index ANI, derived by heart rate variability, to detect painful stimulation during either propofol or sevoflurane anesthesia and changing remifentanil concentrations.

Description:

Monitoring Antinociception during general anesthesia is still a big challenge in the field and has not become clinical routine yet. Recently, for the Surgical Pleth Index SPI a benefit for the patient in terms of reduction of remifentanil use, less unwanted effects and shorter recovery from anesthesia was reported. However, there are new variables like the ANI that are developed to measure antinociception during anesthesia.

In the present study the investigators want to evaluate, whether ANI detects a painful tetanic stimulus during general anesthesia using propofol or sevoflurane and different concentrations of remifentanil.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age between 18- 65 years,

• ASA physical status I or II,

• elective surgery in general anesthesia planned,

• written informed consent

Exclusion Criteria:

• pregnancy,

• history of cardiac arrhythmia,

• presents of any neuromuscular or neurologic disease,

• use of CNS-active medication or abuse of alcohol/illicit drugs -

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• General Anaesthesia

Intervention

Procedure:
• tetanic stimulation
as test stimulus a painful tetanic stimulation is used

Locations

Country	Name	City	State
Germany	University Hospital Kiel, Dept. of Anesthesiology and Intensive Care Med.	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Gruenewald M, Meybohm P, Ilies C, Höcker J, Hanss R, Scholz J, Bein B. Influence of different remifentanil concentrations on the performance of the surgical stress index to detect a standardized painful stimulus during sevoflurane anaesthesia. Br J Anaesth. 2009 Oct;103(4):586-93. doi: 10.1093/bja/aep206. Epub 2009 Jul 31. — View Citation

Struys MM, Vanpeteghem C, Huiku M, Uutela K, Blyaert NB, Mortier EP. Changes in a surgical stress index in response to standardized pain stimuli during propofol-remifentanil infusion. Br J Anaesth. 2007 Sep;99(3):359-67. Epub 2007 Jul 3. — View Citation