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

NCT01522508 | Unknown

• 1 other identifier: ANI-134-1
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

General Anaesthesia

Keywords

Analgesia; Anesthetics; Diagnostic Techniques and Procedures

Study Arms (2)

propofol/remifentanil

patients receive standardized propofol and changing remifentanil concentrations

Procedure: tetanic stimulation

sevoflurane/remifentanil

patients receive standardized sevoflurane and changing remifentanil concentrations

Procedure: tetanic stimulation

Interventions

tetanic stimulation PROCEDURE

as test stimulus a painful tetanic stimulation is used

propofol/remifentanil; sevoflurane/remifentanil

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for elective surgery in general anesthesia

You may qualify if:

• age between 18- 65 years,
• ASA physical status I or II,
• elective surgery in general anesthesia planned,
• written informed consent

You may not qualify if:

• pregnancy,
• history of cardiac arrhythmia,
• presents of any neuromuscular or neurologic disease,
• use of CNS-active medication or abuse of alcohol/illicit drugs -

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

University Hospital Kiel, Dept. of Anesthesiology and Intensive Care Med.

Kiel, 24105, Germany

RECRUITING

Related Publications (3)

• Gruenewald M, Meybohm P, Ilies C, Hocker 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.

  PMID: 19648155 BACKGROUND

• 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. doi: 10.1093/bja/aem173. Epub 2007 Jul 3.

  PMID: 17609248 BACKGROUND

• Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Hocker J, Bein B. Influence of nociceptive stimulation on analgesia nociception index (ANI) during propofol-remifentanil anaesthesia. Br J Anaesth. 2013 Jun;110(6):1024-30. doi: 10.1093/bja/aet019. Epub 2013 Mar 6.

  PMID: 23471754 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Matthias Gruenewald, MD

CONTACT

+49 431 597 2991; matthias.gruenewald@uksh.de

Berthold Bein, MD, PhD, DEAA

CONTACT

+49 431 597 2991; berthold.bein@uksh.de

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: January 26, 2012
• First Posted: January 31, 2012
• Study Start: June 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 15, 2012

Record last verified: 2012-06

Locations

DE (1)