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

This study is currently recruiting participants.
Verified June 2012 by University of Schleswig-Holstein
Sponsor:
Information provided by (Responsible Party):
Berthold Bein, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01522508
First received: January 26, 2012
Last updated: June 14, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
General Anaesthesia
 Procedure: tetanic stimulation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Detection of Nociceptive Stimulation by Analgesia Nociception Index (ANI) During Anesthesia With Propofol or Sevoflurane and Varying Remifentanil Concentrations.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Schleswig-Holstein:

Estimated Enrollment: 50
Study Start Date: June 2011
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
propofol/remifentanil
patients receive standardized propofol and changing remifentanil concentrations
 Procedure: tetanic stimulation
as test stimulus a painful tetanic stimulation is used
sevoflurane/remifentanil
patients receive standardized sevoflurane and changing remifentanil concentrations
 Procedure: tetanic stimulation
as test stimulus a painful tetanic stimulation is used

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients scheduled for elective surgery in general anesthesia

Criteria

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 -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01522508

Contacts
Contact: Matthias Gruenewald, MD +49 431 597 2991 matthias.gruenewald@uksh.de
Contact: Berthold Bein, MD, PhD, DEAA +49 431 597 2991 berthold.bein@uksh.de

Locations
Germany
University Hospital Kiel, Dept. of Anesthesiology and Intensive Care Med. Recruiting
Kiel, Germany, 24105
Contact: Berthold Bein, MD, PhD, DEAA     +49 431 597 2991     berthold.bein@uksh.de    
Principal Investigator: Matthias Gruenewald, MD            
Principal Investigator: Berthold Bein, MD, PhD, DEAA            
Sub-Investigator: Christoph Ilies, MD            
Sub-Investigator: Jan Hoecker, MD            
Sponsors and Collaborators
University of Schleswig-Holstein
  More Information

Publications:

Responsible Party: Berthold Bein, Prof. Dr. med., University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT01522508     History of Changes
Other Study ID Numbers: ANI-134-1
Study First Received: January 26, 2012
Last Updated: June 14, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Schleswig-Holstein:
Analgesia
Anesthetics
Diagnostic Techniques and Procedures

Additional relevant MeSH terms:
Anesthetics
Propofol
Sevoflurane
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
 Anesthetics, General
Hypnotics and Sedatives
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013