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

Not Applicable

Completed

• Conditions: Analgesia
• Interventions: Procedure: standardized pain stimulus

• Registration Number: NCT00791791
• Lead Sponsor: University Hospital Schleswig-Holstein

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.

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Study First Submitted: 2008-11-14
• Study First Submitted QC: 2008-11-14
• Study First Posted: 2008-11-17
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-14
• Last Update Posted: 2012-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	standardized pain stimulus	increasing remifentanil administration
2	standardized pain stimulus	decreasing remifentanil concentration

Primary Outcome Measures

Name	Time	Method
SSI, compared to standard monitoring variables	during anesthesia

Trial Locations

Locations (1)

Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel; 🇩🇪 Kiel, SH, Germany