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

NCT ID: NCT01522508

Last Updated: 2012-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-10-31

Brief Summary

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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

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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.

Conditions

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General Anaesthesia

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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propofol/remifentanil

patients receive standardized propofol and changing remifentanil concentrations

tetanic stimulation

Intervention Type PROCEDURE

as test stimulus a painful tetanic stimulation is used

sevoflurane/remifentanil

patients receive standardized sevoflurane and changing remifentanil concentrations

tetanic stimulation

Intervention Type PROCEDURE

as test stimulus a painful tetanic stimulation is used

Interventions

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tetanic stimulation

as test stimulus a painful tetanic stimulation is used

Intervention Type PROCEDURE

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Schleswig-Holstein

OTHER

Sponsor Role lead

Responsible Party

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Berthold Bein

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Kiel, Dept. of Anesthesiology and Intensive Care Med.

Kiel, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Matthias Gruenewald, MD

Role: CONTACT

+49 431 597 2991

Berthold Bein, MD, PhD, DEAA

Role: CONTACT

+49 431 597 2991

Facility Contacts

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Berthold Bein, MD, PhD, DEAA

Role: primary

+49 431 597 2991

References

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Gruenewald M, Meybohm P, Ilies C, Hocker J, Hanss R, Scholz J, Bein B. Influence of different remifentanil concentrations on the performance of the surgical stress index to detect a standardized painful stimulus during sevoflurane anaesthesia. Br J Anaesth. 2009 Oct;103(4):586-93. doi: 10.1093/bja/aep206. Epub 2009 Jul 31.

Reference Type BACKGROUND
PMID: 19648155 (View on PubMed)

Struys MM, Vanpeteghem C, Huiku M, Uutela K, Blyaert NB, Mortier EP. Changes in a surgical stress index in response to standardized pain stimuli during propofol-remifentanil infusion. Br J Anaesth. 2007 Sep;99(3):359-67. doi: 10.1093/bja/aem173. Epub 2007 Jul 3.

Reference Type BACKGROUND
PMID: 17609248 (View on PubMed)

Gruenewald M, Ilies C, Herz J, Schoenherr T, Fudickar A, Hocker J, Bein B. Influence of nociceptive stimulation on analgesia nociception index (ANI) during propofol-remifentanil anaesthesia. Br J Anaesth. 2013 Jun;110(6):1024-30. doi: 10.1093/bja/aet019. Epub 2013 Mar 6.

Reference Type DERIVED
PMID: 23471754 (View on PubMed)

Other Identifiers

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ANI-134-1

Identifier Type: -

Identifier Source: org_study_id

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