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Surgical Pleth Index (SPI) Guided Analgesia During Sevoflurane Anesthesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Berthold Bein, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01525537
First received: January 26, 2012
Last updated: June 14, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Balanced Anesthesia
 Drug: administration of sufentanil
Drug: sufentanil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Surgical Pleth Index Guided Analgesia With Standard Clinical Practise During Balanced Anesthesia

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Sufentanil consumption [ Time Frame: during induction and end of anesthesia (1-3 hours) ] [ Designated as safety issue: No ]
    We will measure the sufentanil consumption during beginning of anesthesia and extubation in microgram per hour.


Secondary Outcome Measures:
  • hemodynamic stability [ Time Frame: from beginning of anesthesia until discharge to ward (1day) ] [ Designated as safety issue: No ]
    Hemodynamic stability is measured as number of the following events during anesthesia: hypotension, hypertension, tachykardia, bradykardia.


Enrollment: 82
Study Start Date: March 2009
Study Completion Date: October 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPI guided arm
sufentanil was adjusted to SPI level
 Drug: administration of sufentanil
10 microgram sufentanil were given when SPI above 50 for more then 20 sec
Active Comparator: Standard practise
Sufentanil was given at standard practise
 Drug: sufentanil
sufentanil was given at standard practise

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525537

Locations
Germany
University Hospital Kiel, Dept. of Anesthesiology and Intensive Care Med.
Kiel, Germany, 24105
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Study Chair: Berthold Bein, MD, PhD University of Schleswig-Holstein
Principal Investigator: Matthias Gruenewald, MD University of Schleswig-Holstein
  More Information

Publications:

Responsible Party: Berthold Bein, Prof. Dr. med., University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT01525537     History of Changes
Other Study ID Numbers: SPI-134-2
Study First Received: January 26, 2012
Last Updated: June 14, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Schleswig-Holstein:
Anesthesia General
Anesthetics Inhalation
Diagnostic techniques and procedures

Additional relevant MeSH terms:
Anesthetics
Sufentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Narcotics
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on May 21, 2013