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Evaluation of Surgical Stress Index (SSI) During Sevoflurane/Remifentanil Anesthesia

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ClinicalTrials.gov Identifier: NCT00791791
Recruitment Status : Completed
First Posted : November 17, 2008
Last Update Posted : June 15, 2012
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Analgesia Procedure: 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Primary Purpose: Diagnostic
Study Start Date : August 2008
Primary Completion Date : November 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. SSI, compared to standard monitoring variables [ Time Frame: during anesthesia ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791791


Locations
Germany
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Berthold Bein, Prof. Dr. med., University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT00791791     History of Changes
Other Study ID Numbers: SSI-134-1
First Posted: November 17, 2008    Key Record Dates
Last Update Posted: June 15, 2012
Last Verified: June 2012

Keywords provided by Berthold Bein, University of Schleswig-Holstein:
Anesthesia General
Anesthetics Inhalation
Stress measurement
Surgical Stress
Diagnostic Techniques and Procedures

Additional relevant MeSH terms:
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics