Evaluation of Surgical Stress Index (SSI) During Sevoflurane/Remifentanil Anesthesia

Analgesia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00791791
• Other study ID #: SSI-134-1
• Status: Completed
• Phase: N/A
• First received: November 14, 2008
• Last updated: June 14, 2012
• Start date: August 2008
• Est. completion date: November 2008

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 prospective randomized study was to challenge the ability of SSI to detect painful stimulation during sevoflurane - remifentanil anesthesia.

Description:

General anesthesia can be considered as a combination of hypnosis, antinociception and immobility. Whereas monitoring of depth of hypnosis, and muscle relaxation can be regarded as accepted, determination of the nociception is based on clinical signs like somatic or autonomic responses.

Recently, the multivariate surgical stress index (SSI)has been demonstrated to correlate with surgical stress intensity. Thus, SSI might be a useful variable to adjust analgesic drug administration in individual patients.

We want to investigate whether SSI is able to indicate nociception following standardized noxious stimulation during balanced sevoflurane - remifentanil anesthesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age between 18 and 65 years

• ASA physical status 1-2

• elective surgery in general anesthesia of 1 to 2 hours

• written informed consent

Exclusion Criteria:

• pregnancy

• history of cardiac arrhythmia

• presence of any neuromuscular or neurological disease

• use of CNS-active medication or abuse of alcohol or illicit drugs

Study Design

Allocation: Randomized, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Analgesia

Intervention

Procedure:
• standardized pain stimulus
a tetanic stimulus (30s, 50 Hz, 60mA) applied as standardized pain stimulus

Locations

Country	Name	City	State
Germany	Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel	Kiel	SH

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Gruenewald M, Zhou J, Schloemerkemper N, Meybohm P, Weiler N, Tonner PH, Scholz J, Bein B. M-Entropy guidance vs standard practice during propofol-remifentanil anaesthesia: a randomised controlled trial. Anaesthesia. 2007 Dec;62(12):1224-9. — View Citation

Huiku M, Uutela K, van Gils M, Korhonen I, Kymäläinen M, Meriläinen P, Paloheimo M, Rantanen M, Takala P, Viertiö-Oja H, Yli-Hankala A. Assessment of surgical stress during general anaesthesia. Br J Anaesth. 2007 Apr;98(4):447-55. Epub 2007 Feb 28. — View Citation

Rehberg B, Grünewald M, Baars J, Fuegener K, Urban BW, Kox WJ. Monitoring of immobility to noxious stimulation during sevoflurane anesthesia using the spinal H-reflex. Anesthesiology. 2004 Jan;100(1):44-50. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SSI, compared to standard monitoring variables		during anesthesia	No