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Clinical Trials/NCT01525537
NCT01525537
Completed
Not Applicable

Comparison of Surgical Pleth Index Guided Analgesia With Standard Clinical Practise During Balanced Anesthesia

University Hospital Schleswig-Holstein1 site in 1 country82 target enrollmentMarch 2009

Overview

Phase
Not Applicable
Intervention
administration of sufentanil
Conditions
Balanced Anesthesia
Sponsor
University Hospital Schleswig-Holstein
Enrollment
82
Locations
1
Primary Endpoint
Sufentanil consumption
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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.

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

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
October 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital Schleswig-Holstein
Responsible Party
Principal Investigator
Principal Investigator

Berthold Bein

Prof. Dr. med.

University Hospital Schleswig-Holstein

Eligibility 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 -

Arms & Interventions

SPI guided arm

sufentanil was adjusted to SPI level

Intervention: administration of sufentanil

Standard practise

Sufentanil was given at standard practise

Intervention: sufentanil

Outcomes

Primary Outcomes

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 Outcomes

  • hemodynamic stability(from beginning of anesthesia until discharge to ward (1day))

Study Sites (1)

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