Clinical trial NCT00791791: Evaluation of Surgical Stress Index (SSI) During Sevoflurane/Remifentanil Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Keywords: Anesthesia General
Anesthetics Inhalation
Stress measurement
Surgical Stress
Diagnostic Techniques and Procedures
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2008-11-17
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the present prospective randomized study was to challenge the ability of SSI to detect painful stimulation during sevoflurane - remifentanil anesthesia.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: SSI, compared to standard monitoring variables
timeFrame: during anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel
state: SH
Study officials:
affiliation: Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel
name: Matthias Gruenewald, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel
name: Berthold Bein, MD, DEAA
role: STUDY_CHAIR
References:
citation: Huiku M, Uutela K, van Gils M, Korhonen I, Kymalainen M, Merilainen P, Paloheimo M, Rantanen M, Takala P, Viertio-Oja H, Yli-Hankala A. Assessment of surgical stress during general anaesthesia. Br J Anaesth. 2007 Apr;98(4):447-55. doi: 10.1093/bja/aem004. Epub 2007 Feb 28.
citation: 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. doi: 10.1111/j.1365-2044.2007.05252.x.
citation: Rehberg B, Grunewald 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. doi: 10.1097/00000542-200401000-00011.
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.