Completed

NCT Number: NCT01525537

Surgical Pleth Index (SPI) Guided Analgesia During Sevoflurane Anesthesia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Balanced Anesthesia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Kiel, Dept. of Anesthesiology and Intensive Care Med.

Kiel, 24105, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

administration of sufentanil

Drug

10 microgram sufentanil were given when SPI above 50 for more then 20 sec

Sufentanil

Drug

sufentanil was given at standard practise

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

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.

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2011
First posted: Feb 3, 2012
Registry last updated: Jun 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.