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Evaluation of the Surgical Pleth Index During Spinal and General Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00789438
Recruitment Status : Completed
First Posted : November 11, 2008
Results First Posted : February 19, 2010
Last Update Posted : July 13, 2010
Information provided by:

Study Description
Brief Summary:
The Surgical Pleth index (SPI) 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 SPI and aching procedures and a negative correlation between SPI and the remifentanil dosage. Hence, it was concluded that SPI may be a bedside tool to measure `pain` during surgery. So far, no study investigated SPI during regional anaesthesia.

Condition or disease
Stress Pain

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

Study Design

Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effects of Sedation and Analgesia on the Surgical Pleth Index (SPI)
Study Start Date : October 2008
Primary Completion Date : January 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Groups and Cohorts

General Anesthesia
Patients undergoing short-term surgery (30-90 min) under general anesthesia
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

Outcome Measures

Primary Outcome Measures :
  1. Difference Between All Groups for the Surgical Pleth Index(SPI) at Defined Timepoints [ Time Frame: Time points for outcome measures: Baseline, before Induction of anesthesia, during Intubation or Spinal Punction, during Skin Incision, during Surgical Suture, during Post Anesthesia Care Unit stay ]
    Surgical Pleth Index (SPI), derived from finger photoplethysmographic signal has a range from 0 showing the lowest stress level to 100 showing the maximum stress level. SPI was compared between the groups during six defined time points: baseline (BL)- day before surgery; induction (IND)-before induction of general anesthesia or before spinal punction respectively; intubation (INT) or spinal punction (SPA); skin incision (INC), surgical suture (SU) and 10 minutes after admission to the recovery room (PACU). Difference between the groups is calculated using ANOVA.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients scheduled for short-term (30-90 min) surgery.

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

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): NCT00789438

Institut für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24105
Sponsors and Collaborators
University of Schleswig-Holstein
Study Director: Berthold Bein, PD Dr med Institut für Anästhesiologie und operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel
More Information

Responsible Party: Berthold Bein, Institut für Anästhesiologie und Operative Intensivmedizin, Campus Kiel
ClinicalTrials.gov Identifier: NCT00789438     History of Changes
Other Study ID Numbers: SSI-154-02
First Posted: November 11, 2008    Key Record Dates
Results First Posted: February 19, 2010
Last Update Posted: July 13, 2010
Last Verified: October 2009

Keywords provided by University of Schleswig-Holstein:
Surgical Stress

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs