Evaluation of the Surgical Pleth Index During Spinal and General Anesthesia

Pain Clinical Trial

Official title:

The Effects of Sedation and Analgesia on the Surgical Pleth Index (SPI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00789438
• Other study ID #: SSI-154-02
• Status: Completed
• Phase: N/A
• First received: November 10, 2008
• Last updated: July 6, 2010
• Start date: October 2008
• Est. completion date: May 2010

Study information

• Verified date: October 2009
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: May 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain
• Stress

Locations

Country	Name	City	State
Germany	Institut für Anästhesiologie und Operative Intensivmedizin, Universitätsklinikum Schleswig-Holstein, Campus Kiel	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference Between All Groups for the Surgical Pleth Index(SPI) at Defined Timepoints	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.	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	No