Clinical Trials Directory

Trials / Completed

CompletedNCT00789438

Evaluation of the Surgical Pleth Index During Spinal and General Anesthesia

The Effects of Sedation and Analgesia on the Surgical Pleth Index (SPI)

Status
Completed
Phase
Study type
Observational
Enrollment
69 (actual)
Sponsor
University Hospital Schleswig-Holstein · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The Surgical Pleth index (SPI) has been introduced as a non invasive tool to "measure" stress and pain during surgery. Preliminary studies were performed in patients under general anaesthesia with propofol and remifentanil. These trials showed a good correlation between SPI and aching procedures and a negative correlation between SPI and the remifentanil dosage. Hence, it was concluded that SPI may be a bedside tool to measure 'pain' during surgery. So far, no study investigated SPI during regional anaesthesia.

Detailed description

1. Spinal anaesthesia secures full pain relieve and muscle relaxation usually in the lower part of the body. Thus, SPI - a measure that reflects pain during surgery - may not exceed significantly compared to baseline. It may slightly increase only during administration of the block. 2. Increasing SPI values due to surgery under subarachnoid block may reflect intraoperative patient's stress mediated by activation of the autonomic nervous system, specifically sympathetic activation. 3. In consistence with previously published data no changes of SPI should occur due to standardized sedation with propofol.

Conditions

Timeline

Start date
2008-10-01
Primary completion
2010-01-01
Completion
2010-05-01
First posted
2008-11-11
Last updated
2010-07-13
Results posted
2010-02-19

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT00789438. Inclusion in this directory is not an endorsement.