Trials / Completed
CompletedNCT01525537
Surgical Pleth Index (SPI) Guided Analgesia During Sevoflurane Anesthesia
Comparison of Surgical Pleth Index Guided Analgesia With Standard Clinical Practise During Balanced Anesthesia
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 82 (actual)
- Sponsor
- University Hospital Schleswig-Holstein · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | administration of sufentanil | 10 microgram sufentanil were given when SPI above 50 for more then 20 sec |
| DRUG | sufentanil | sufentanil was given at standard practise |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2010-02-01
- Completion
- 2011-10-01
- First posted
- 2012-02-03
- Last updated
- 2012-06-15
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01525537. Inclusion in this directory is not an endorsement.