Clinical trial NCT01525537: Surgical Pleth Index (SPI) Guided Analgesia During Sevoflurane Anesthesia
Official title: Comparison of Surgical Pleth Index Guided Analgesia With Standard Clinical Practise During Balanced Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balanced Anesthesia
Keywords: Anesthesia General
Anesthetics Inhalation
Diagnostic techniques and procedures
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2012-02-03
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 -

Primary outcomes:
measure: Sufentanil consumption
timeFrame: during induction and end of anesthesia (1-3 hours)
Secondary outcomes:
measure: hemodynamic stability
timeFrame: from beginning of anesthesia until discharge to ward (1day)
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: University Hospital Kiel, Dept. of Anesthesiology and Intensive Care Med.
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Berthold Bein, MD, PhD
role: STUDY_CHAIR
affiliation: University Hospital Schleswig-Holstein
name: Matthias Gruenewald, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Gruenewald M, Willms S, Broch O, Kott M, Steinfath M, Bein B. Sufentanil administration guided by surgical pleth index vs standard practice during sevoflurane anaesthesia: a randomized controlled pilot study. Br J Anaesth. 2014 May;112(5):898-905. doi: 10.1093/bja/aet485. Epub 2014 Feb 16.