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Completed

NCT Number: NCT00791791

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

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

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Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, D-24105, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standardized pain stimulus

Procedure

a tetanic stimulus (30s, 50 Hz, 60mA) applied as standardized pain stimulus

Primary outcomes

  1. SSI, compared to standard monitoring variables

    Time frame: during anesthesia

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Nov 17, 2008
Registry last updated
Jun 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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