Evaluation of Surgical Stress Index (SSI) During Sevoflurane/Remifentanil Anesthesia - Full Text View

Sponsor:	University of Schleswig-Holstein
Information provided by:	University of Schleswig-Holstein
ClinicalTrials.gov Identifier:	NCT00791791

Purpose

The aim of the present prospective randomized study was to challenge the ability of SSI to detect painful stimulation during sevoflurane - remifentanil anesthesia.

Condition	Intervention
Analgesia	Procedure: standardized pain stimulus

Study Type:	Interventional
Study Design:	Diagnostic, Randomized

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Surgery

U.S. FDA Resources

Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:

SSI, compared to standard monitoring variables [ Time Frame: during anesthesia ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	August 2008
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 increasing remifentanil administration	Procedure: standardized pain stimulus a tetanic stimulus (30s, 50 Hz, 60mA) applied as standardized pain stimulus
2 decreasing remifentanil concentration	Procedure: standardized pain stimulus a tetanic stimulus (30s, 50 Hz, 60mA) applied as standardized pain stimulus

Detailed Description:

General anesthesia can be considered as a combination of hypnosis, antinociception and immobility. Whereas monitoring of depth of hypnosis, and muscle relaxation can be regarded as accepted, determination of the nociception is based on clinical signs like somatic or autonomic responses.

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

age between 18 and 65 years
ASA physical status 1-2
elective surgery in general anesthesia of 1 to 2 hours
written informed consent

Exclusion Criteria:

pregnancy
history of cardiac arrhythmia
presence of any neuromuscular or neurological disease
use of CNS-active medication or abuse of alcohol or illicit drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791791

Locations

Germany, SH
Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel
Kiel, SH, Germany, D-24105

Sponsors and Collaborators

University of Schleswig-Holstein

Investigators

Principal Investigator:	Matthias Gruenewald, MD	Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel
Study Chair:	Berthold Bein, MD, DEAA	Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel

More Information

Publications:

Huiku M, Uutela K, van Gils M, Korhonen I, Kymäläinen M, Meriläinen P, Paloheimo M, Rantanen M, Takala P, Viertiö-Oja H, Yli-Hankala A. Assessment of surgical stress during general anaesthesia. Br J Anaesth. 2007 Apr;98(4):447-55. 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.

Rehberg B, Grünewald 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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Gruenewald M, Meybohm P, Ilies C, Höcker 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. Epub 2009 Jul 31.

Responsible Party:	University Hospital Schleswig Holstein ( PD Dr. Berthold Bein DEAA )
Study ID Numbers:	SSI-134-1
Study First Received:	November 14, 2008
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00791791 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Schleswig-Holstein:

Anesthesia General
Anesthetics Inhalation
Stress measurement
Surgical Stress
Diagnostic Techniques and Procedures

ClinicalTrials.gov processed this record on November 27, 2009