In the current study we will measure CVI in ASA 1-3 patients during elective abdominal surgery under fentanyl/sevoflurane/epidural anesthesia. We will monitor patient movement as primary correlate to CVA and cardiovascular parameters as secondary…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
periopertieve pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
EEG parameters - movement during anesthesia
Secondary outcome
cardiac output and blood pressure
Background summary
Anesthesia has made enormous progress in the last couple of decades making
surgery a reliable and safe procedure with minimal morbidity and mortality.
Despite the progress many aspects of anesthesia remain elusive. Two important
items that have recently been the focus of attention are the measurement of the
depth of anesthesia and the measurement of nociception (or *pain-related
afferent input*) during anesthesia. The current study will focus on the latter
of these two items: measurement of nociception during anesthesia. In order to
get an indication of nociception we will make use of a recently developed index
from the frontal EEG and EMG, the Composite Variability Index (CVI) by Aspect
medical Systems. The CVI is based on the observations that the EEG-related
variable BIS (bispectral index) rapidly responds to painful surgical stimuli
during anesthesia and that the BIS waveform and EMG are more variable in case
of a low analgesic load. This indicates that when insufficient amounts of
analgesics have been infusion the BIS response (ie increase) to a surgical
stimulus will be larger but also that the BIS and EMG display increased
variability. The CVI is based on the standard deviation of BIS and EMG (sBIS
and sEMG). The CVI combines sBIS and sEMG into a single measure of variability
ranging from 0 to 100. Preliminary data suggest a possible predictive effect of
the initial change in CVI just prior to a patient movement.
Study objective
In the current study we will measure CVI in ASA 1-3 patients during elective
abdominal surgery under fentanyl/sevoflurane/epidural anesthesia. We will
monitor patient movement as primary correlate to CVA and cardiovascular
parameters as secondary correlates (eg, cardiac output, pulse transit time,
blood pressure and heart rate).
Study design
Observational
Study burden and risks
Limited; a minor risk is expected from teh arterial line
Albinusdreef 2
2333 ZA Leiden
NL
Albinusdreef 2
2333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
Age: 18-80 years;
Sex: male or female;
Surgery: elective abdominal surgery lasting at least 2 hours. This includes gynecological procedures (eg., abdominal hysterectomies), urological procedures (eg., radical prostatectomies), GI-surgery (eg., colon surgery);
ASA status: 1, 2 or 3.
Exclusion criteria
Age: < 18 or > 80 years;
Unable to give written informed consent;
Pregnancy/lactation;
Extreme obesity: BMI > 35;
Perceived difficult intubation requiring muscle relaxation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL28528.058.09 |