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

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ClinicalTrials.gov Identifier: NCT01522508
Recruitment Status : Unknown
Verified June 2012 by Berthold Bein, University of Schleswig-Holstein.
Recruitment status was:  Recruiting
First Posted : January 31, 2012
Last Update Posted : June 15, 2012
Sponsor:
Information provided by (Responsible Party):
Berthold Bein, University of Schleswig-Holstein

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.

Condition or disease Intervention/treatment
General Anaesthesia Procedure: tetanic stimulation

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.


Study Type : Observational
Estimated Enrollment : 50 participants
Time Perspective: Prospective
Official Title: Detection of Nociceptive Stimulation by Analgesia Nociception Index (ANI) During Anesthesia With Propofol or Sevoflurane and Varying Remifentanil Concentrations.
Study Start Date : June 2011
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Group/Cohort Intervention/treatment
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





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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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 -

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

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 Posted: January 31, 2012    Key Record Dates
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