Surgical Pleth Index (SPI) Guided Analgesia During Sevoflurane Anesthesia

Study Overview
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Brief Summary
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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
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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: SPI guided analgesia will result in less sufentanil consumption 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

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

Conditions
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Balanced Anesthesia

Intervention / Treatment
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* Drug: administration of sufentanil
* Drug: sufentanil


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPI guided arm<br>sufentanil was adjusted to SPI level | Drug: administration of sufentanil<br>* 10 microgram sufentanil were given when SPI above 50 for more then 20 sec<br>|
| Active Comparator: Standard practise<br>Sufentanil was given at standard practise | Drug: sufentanil<br>* sufentanil was given at standard practise<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia General, Anesthetics Inhalation, Diagnostic techniques and procedures