Trials / Completed
CompletedNCT01928875
Comparison of Adequacy of Anesthesia Monitoring With Standard Clinical Practice During Routine General Anesthesia
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 496 (actual)
- Sponsor
- GE Healthcare · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to demonstrate that using Surgical Pleth Index (SPI) and Entropy in adjunct to other clinical information decreases the occurrence rate of inadequate anesthesia events, bradycardia and hypotension in comparison to standard clinical practice during anesthesia. Adequacy of Anesthesia (AoA) monitoring comprises the use of both Entropy and SPI measurements. Adequacy of anesthesia will be monitored using non-invasive blood pressure, blood oxygen saturation (SpO2), ECG, and neuromuscular transmission (NMT).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AoA Monitoring | Monitoring with Entropy and SPI parameters during surgery |
| DEVICE | Routine (Standard) Anesthesia Monitoring | Standard of care monitoring |
Timeline
- Start date
- 2013-12-01
- Primary completion
- 2017-02-01
- First posted
- 2013-08-27
- Last updated
- 2017-05-01
Locations
4 sites across 4 countries: Finland, Germany, Hungary, Netherlands
Source: ClinicalTrials.gov record NCT01928875. Inclusion in this directory is not an endorsement.