Discrimination Between the Effects of Sedation and Analgesia on the Surgical Stress Index (SSI) - Full Text View

Sponsored by:	University of Schleswig-Holstein
Information provided by:	University of Schleswig-Holstein
ClinicalTrials.gov Identifier:	NCT00789438

Purpose

The Surgical Stress index (SSI) has been introduced as a non invasive tool to "measure" stress and pain during surgery. Preliminary studies were performed in patients under general anaesthesia with Propofol and Remifentanil. These trials showed a good correlation between SSI and aching procedures and a negative correlation between SSI and the Remifentanil dosage. Hence, it was concluded that SSI may be a bedside tool to measure `pain` during surgery. So far, no study investigated SSI during regional anaesthesia.

Condition
Analgesia Sedation Anesthesia,Spinal

MedlinePlus related topics: Anesthesia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Cross-Sectional
Official Title:	The Effects of Sedation and Analgesia on the Surgical Stress Index (SSI)

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

Primary Outcome Measures:

SSI during spinal or general anesthesia compared to baseline [ Time Frame: during surgery ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	60
Study Start Date:	October 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
General Anesthesia Patients undergoing short-term surgery (30-90 min) under general anesthesia
Spinal Patients undergoing short-term surgery (30-90 min) under spinal anesthesia
Spinal + Sedation Patients undergoing short-term surgery (30-90 min) under spinal anesthesia with sedation

Detailed Description:

Spinal anaesthesia secures full pain relieve and muscle relaxation usually in the lower part of the body. Thus, SSI - a measure that reflects pain during surgery - may not exceed significantly compared to baseline. It may slightly increase only during administration of the block.
Increasing SSI values due to surgery under subarachnoid block may reflect intraoperative patient's stress mediated by activation of the autonomic nervous system, specifically sympathetic activation.
In consistence with previously published data no changes of SSI should occur due to standardized sedation with propofol.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients scheduled for short-term (30-90 min) surgery.

Criteria

Inclusion Criteria:

surgical procedures feasible under general or spinal anesthesia
duration between 30 and 90 min
ASA status I,II or III

Exclusion Criteria:

contraindications against one of the anesthesia methods
age under 18
emergencies
chronical pain history
lack of sinus rhythm

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789438

Locations

Germany
Institut für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel	Recruiting
Kiel, Germany, 24105
Contact: Christoph Ilies 0049-5972991 ilies@anaesthesie.uni-kiel.de
Principal Investigator: Berthold Bein, PD Dr med
Sub-Investigator: Christoph Ilies

Sponsors and Collaborators

University of Schleswig-Holstein

Investigators

Study Chair:

Jens Scholz, Prof Dr med

Institut für Anästhesiologie und operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel

More Information

Responsible Party:	Institut für Anästhesiologie und Operative Intensivmedizin, Campus Kiel ( Berthold Bein )
Study ID Numbers:	SSI-154-02
Study First Received:	November 10, 2008
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00789438
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Schleswig-Holstein:

Analgesia
Sedation
Spinal

Stress
Surgical
Surgical Stress

Study placed in the following topic categories:

Stress

ClinicalTrials.gov processed this record on January 16, 2009