Evaluation of the Surgical Pleth Index During Spinal and General Anesthesia

NCT00789438 | Completed Results

• 1 other identifier: SSI-154-02
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Pain

Keywords

Analgesia; Sedation; Spinal; Stress; Surgical; Surgical Stress; Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

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

Kiel, 24105, Germany

Location

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Christoph Ilies M.D.
• Organization: Institut für Anästhesiologie und Operative Intensivmedizin, Universitätsklinukum Schleswig-Holstein, Campus Kiel

christoph.ilies@anaesthesie.uni-kiel.de

+49-431-597

Study Officials

• Berthold Bein, PD Dr med

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 10, 2008
• First Posted: November 11, 2008
• Study Start: October 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 13, 2010
• Results First Posted: February 19, 2010

Record last verified: 2009-10

Locations

DE (1)