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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Berthold Bein, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00791791
First received: November 14, 2008
Last updated: June 14, 2012
Last verified: June 2012
  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: Allocation: Randomized
Primary Purpose: Diagnostic

Resource links provided by NLM:


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
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Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: November 14, 2008
Last Updated: June 14, 2012
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on August 18, 2014