Evaluation of Surgical Stress Index (SSI) During Sevoflurane/Remifentanil Anesthesia
NCT ID: NCT00791791
Last Updated: 2012-06-15
Study Results
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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COMPLETED
NA
24 participants
INTERVENTIONAL
2008-08-31
2008-11-30
Brief Summary
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Detailed Description
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Recently, the multivariate surgical stress index (SSI)has been demonstrated to correlate with surgical stress intensity. Thus, SSI might be a useful variable to adjust analgesic drug administration in individual patients.
We want to investigate whether SSI is able to indicate nociception following standardized noxious stimulation during balanced sevoflurane - remifentanil anesthesia.
Conditions
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Study Design
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RANDOMIZED
DIAGNOSTIC
Study Groups
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1
increasing remifentanil administration
standardized pain stimulus
a tetanic stimulus (30s, 50 Hz, 60mA) applied as standardized pain stimulus
2
decreasing remifentanil concentration
standardized pain stimulus
a tetanic stimulus (30s, 50 Hz, 60mA) applied as standardized pain stimulus
Interventions
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standardized pain stimulus
a tetanic stimulus (30s, 50 Hz, 60mA) applied as standardized pain stimulus
Eligibility Criteria
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Inclusion Criteria
* ASA physical status 1-2
* elective surgery in general anesthesia of 1 to 2 hours
* written informed consent
Exclusion Criteria
* history of cardiac arrhythmia
* presence of any neuromuscular or neurological disease
* use of CNS-active medication or abuse of alcohol or illicit drugs
18 Years
65 Years
FEMALE
No
Sponsors
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University Hospital Schleswig-Holstein
OTHER
Responsible Party
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Berthold Bein
Prof. Dr. med.
Principal Investigators
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Matthias Gruenewald, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel
Berthold Bein, MD, DEAA
Role: STUDY_CHAIR
Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel
Locations
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Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, Germany
Countries
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References
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Huiku M, Uutela K, van Gils M, Korhonen I, Kymalainen M, Merilainen P, Paloheimo M, Rantanen M, Takala P, Viertio-Oja H, Yli-Hankala A. Assessment of surgical stress during general anaesthesia. Br J Anaesth. 2007 Apr;98(4):447-55. doi: 10.1093/bja/aem004. Epub 2007 Feb 28.
Gruenewald M, Zhou J, Schloemerkemper N, Meybohm P, Weiler N, Tonner PH, Scholz J, Bein B. M-Entropy guidance vs standard practice during propofol-remifentanil anaesthesia: a randomised controlled trial. Anaesthesia. 2007 Dec;62(12):1224-9. doi: 10.1111/j.1365-2044.2007.05252.x.
Rehberg B, Grunewald M, Baars J, Fuegener K, Urban BW, Kox WJ. Monitoring of immobility to noxious stimulation during sevoflurane anesthesia using the spinal H-reflex. Anesthesiology. 2004 Jan;100(1):44-50. doi: 10.1097/00000542-200401000-00011.
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.
Other Identifiers
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SSI-134-1
Identifier Type: -
Identifier Source: org_study_id
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