Surgical Pleth Index (SPI) Guided Analgesia During Sevoflurane Anesthesia

Overview

The aim of the present study was to compare SPI guided analgesia with standard clinical practise during general anesthesia using a balanced setting of sevoflurane and sufentanil anesthesia. It was to be tested whether SPI guided analgesia leads to more cardiovascular stability, less use of analgetics and shorter recovery from anesthesia.

Full Title of Study: “Comparison of Surgical Pleth Index Guided Analgesia With Standard Clinical Practise During Balanced Anesthesia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: February 2010

Detailed Description

General anesthesia can be considered as a combination of hypnosis, antinociception, and immobility. The monitoring of hypnosis and immobility has been established in clinical practise, however for the evaluation of antinociception a valid monitoring is missing. The Surgical Pleth Index (SPI; former named Surgical Stress Index-SSI) is a multivariate index derived non invasively from finger plethysmographic signal. It has been demonstrated to correlate with surgical stress intensity. In the setting of total intravenous anesthesia TIVA our group could show beneficial effects of SPI guided analgesia in terms of remifentanil consumption, hemodynamic stability and incidence of unwanted events. Therefore, we wanted examine whether these beneficial effects of SPI guided anesthesia can be transferred to a setting of balanced anesthesia using a volatile anesthetic sevoflurane and the opioid sufentanil. The following hypotheses have been made: 1. SPI guided analgesia will result in less sufentanil consumption 2. SPI guided analgesia will result in more hemodynamic stability and faster recovery of the patient after anesthesia, and less opioid use in post operative period

Interventions

  • Drug: administration of sufentanil
    • 10 microgram sufentanil were given when SPI above 50 for more then 20 sec
  • Drug: sufentanil
    • sufentanil was given at standard practise

Arms, Groups and Cohorts

  • Experimental: SPI guided arm
    • sufentanil was adjusted to SPI level
  • Active Comparator: Standard practise
    • Sufentanil was given at standard practise

Clinical Trial Outcome Measures

Primary Measures

  • Sufentanil consumption
    • Time Frame: during induction and end of anesthesia (1-3 hours)
    • We will measure the sufentanil consumption during beginning of anesthesia and extubation in microgram per hour.

Secondary Measures

  • hemodynamic stability
    • Time Frame: from beginning of anesthesia until discharge to ward (1day)
    • Hemodynamic stability is measured as number of the following events during anesthesia: hypotension, hypertension, tachykardia, bradykardia.

Participating in This Clinical Trial

Inclusion Criteria

  • age between 18 – 65 years – ASA physical status I or II – elective surgery under general anesthesia of 1-2 hours – written informed consent Exclusion Criteria:

  • pregnancy – history of cardiac arrhythmia – presence of any neuromuscular opr neurologic disease – use of CNS active medication or alcohol/illicit drug abuse -

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital Schleswig-Holstein
  • Provider of Information About this Clinical Study
    • Principal Investigator: Berthold Bein, Prof. Dr. med. – University Hospital Schleswig-Holstein
  • Overall Official(s)
    • Berthold Bein, MD, PhD, Study Chair, University Hospital Schleswig-Holstein
    • Matthias Gruenewald, MD, Principal Investigator, University Hospital Schleswig-Holstein

References

Chen X, Thee C, Gruenewald M, Wnent J, Illies C, Hoecker J, Hanss R, Steinfath M, Bein B. Comparison of surgical stress index-guided analgesia with standard clinical practice during routine general anesthesia: a pilot study. Anesthesiology. 2010 May;112(5):1175-83. doi: 10.1097/ALN.0b013e3181d3d641.

Gruenewald M, Meybohm P, Ilies C, Hocker J, Hanss R, Scholz J, Bein B. Influence of different remifentanil concentrations on the performance of the surgical stress index to detect a standardized painful stimulus during sevoflurane anaesthesia. Br J Anaesth. 2009 Oct;103(4):586-93. doi: 10.1093/bja/aep206. Epub 2009 Jul 31.

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