Surgical Pleth Index (SPI) Guided Analgesia During Sevoflurane Anesthesia

Balanced Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01525537
• Other study ID #: SPI-134-2
• Status: Completed
• Phase: N/A
• First received: January 26, 2012
• Last updated: June 14, 2012
• Start date: March 2009
• Est. completion date: October 2011

Study information

• Verified date: June 2012
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: October 2011
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Balanced Anesthesia

Intervention

Drug:
• administration of sufentanil
10 microgram sufentanil were given when SPI above 50 for more then 20 sec
• sufentanil
sufentanil was given at standard practise

Locations

Country	Name	City	State
Germany	University Hospital Kiel, Dept. of Anesthesiology and Intensive Care Med.	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

Gruenewald M, Meybohm P, Ilies C, Höcker 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No