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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Berthold Bein, University of Schleswig-Holstein.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01522508
First Posted: January 31, 2012
Last Update Posted: June 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Berthold Bein, University of Schleswig-Holstein
  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:


Further study details as provided by Berthold Bein, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: January 26, 2012
First Posted: January 31, 2012
Last Update Posted: June 15, 2012
Last Verified: June 2012

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

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