Evaluation of the Surgical Pleth Index During Spinal and General Anesthesia

This study has been completed.
Sponsor:
Information provided by:
University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00789438
First received: November 10, 2008
Last updated: July 6, 2010
Last verified: October 2009
  Purpose

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
Stress
Pain

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effects of Sedation and Analgesia on the Surgical Pleth Index (SPI)

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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 69
Study Start Date: October 2008
Study Completion Date: May 2010
Primary Completion Date: January 2010 (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:
  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.
  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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00789438

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

No publications provided

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
Study First Received: November 10, 2008
Results First Received: October 27, 2009
Last Updated: July 6, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University of Schleswig-Holstein:
Analgesia
Sedation
Spinal
Stress
Surgical
Surgical Stress
Pain

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014