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

Sponsor
University Hospital Schleswig-Holstein (Other)
Overall Status
Unknown status
CT.gov ID
NCT01522508
Collaborator
(none)
50
Enrollment
1
Location
16
Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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 Design

Study Type:
Observational
Anticipated 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 :
Jun 1, 2011
Anticipated Primary Completion Date :
Jul 1, 2012
Anticipated Study Completion Date :
Oct 1, 2012

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University Hospital Kiel, Dept. of Anesthesiology and Intensive Care Med. Kiel Germany 24105

    Sponsors and Collaborators

    • University Hospital Schleswig-Holstein

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Berthold Bein, Prof. Dr. med., University Hospital Schleswig-Holstein
    ClinicalTrials.gov Identifier:
    NCT01522508
    Other Study ID Numbers:
    • ANI-134-1
    First Posted:
    Jan 31, 2012
    Last Update Posted:
    Jun 15, 2012
    Last Verified:
    Jun 1, 2012
    Keywords provided by Berthold Bein, Prof. Dr. med., University Hospital Schleswig-Holstein
    Analgesia
    Anesthetics
    Diagnostic Techniques and Procedures

    Study Results

    No Results Posted as of Jun 15, 2012