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Clinical Trials/NCT01522508
NCT01522508
Unknown
Not Applicable

Detection of Nociceptive Stimulation by Analgesia Nociception Index (ANI) During Anesthesia With Propofol or Sevoflurane and Varying Remifentanil Concentrations.

University Hospital Schleswig-Holstein1 site in 1 country50 target enrollmentJune 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
General Anaesthesia
Sponsor
University Hospital Schleswig-Holstein
Enrollment
50
Locations
1
Last Updated
13 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
October 2012
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital Schleswig-Holstein
Responsible Party
Principal Investigator
Principal Investigator

Berthold Bein

Prof. Dr. med.

University Hospital Schleswig-Holstein

Eligibility 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 -

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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