Comparing to the control group where adequacy of anesthesia is monitored using NIBP, SpO2, ECG and NMT, the occurrence rate of inadequate anesthesia events, bradycardia and hypotension in subjects undergoing surgery is lower when Entropy and SPI…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
specifieke aandoeningen zijn niet van belang voor het onderzoek
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Incidence of hemodynamic instability including hypertension, hypotension,
tachycardia and bradycardia
• Incidence of subject movements including somatic arousal, somatic response
Secondary outcome
• Amount of anesthetic and analgesic drugs used
• Time points of the operation (start of monitoring, induction, loss of
consciousness, intubation, start of surgery, maximum surgical stimuli, end of
surgery, discontinuation of anesthetics, open eyes on verbal command (emergence
from anesthesia), extubation)
• In the recovery room, the modified Aldrete-Score, postoperative nausea and
vomiting, and pain using a 0-10 numerical pain intensity rating (Visual Analog
Scale, VAS) scale are recorded.
• On the first postoperative day, all subjects are asked by a blinded
investigator if they had any memory or awareness during anesthesia and the
level of satisfaction with the whole surgical procedure using a 0-100 scale.
• SPI and Entropy values from the test group
Background summary
This is a clinical multicenter study to demonstrate, that using 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. Current scientific literature
suggests that using SPI and Entropy measurements gives at least as good
indication of the level of analgesia compared to traditional approaches, such
as observing physiological changes (hypertension, tachycardia, grimacing and
movement during anesthesia).
Study objective
Comparing to the control group where adequacy of anesthesia is monitored using
NIBP, SpO2, ECG and NMT, the occurrence rate of inadequate anesthesia events,
bradycardia and hypotension in subjects undergoing surgery is lower when
Entropy and SPI monitoring is used in addition to NIBP, SpO2, ECG and NMT.
Study design
This is a prospective post-market, multi-site, blinded (at postoperative stage,
not in Operation Room), randomized, parallel comparison study
Intervention
extra non-invasive monitoring of Entropie and SPI to measure adequacy of
analgesia
Study burden and risks
As patients get standard anesthesia with standard monitoring, no risk or burden
is related to the study
Kuortaneenkatu 2
Helsinki FI-00510
FI
Kuortaneenkatu 2
Helsinki FI-00510
FI
Listed location countries
Age
Inclusion criteria
• Age 18-80 years of age
• Surgery that is expected to last at least 2 hours under general anesthesia with endotracheal tube
Exclusion criteria
• Any subject with a cardiac pacemaker
• Any subject with atrial fibrillation at the time of obtaining the baseline values
• Any subject with more than 5 ventricular extra systoles/minute at the time of obtaining the baseline values
• Any subject who needs invasive blood pressure measurement
• Any subject who show hemodynamics that would have qualified for being considered as a sign of inadequate anesthesia already at baseline
• Any subject with epidural anesthesia or analgesia during the surgery. Epidural catheter may be placed pre-operatively, and used in the PACU, but not during the surgery
• Any subject having surgery that requires prone position
• Any subject with very high body mass index (>35) because of incompatibility with the target controlled anesthesia models used
• Any subject with known allergies to the specific anesthetic agents/ analgesic drugs intended for use in their surgeries
• Any subject with laryngeal mask airway
• Any subject who is going to have major surgery with a high risk of extensive blood loss
• Any subject with known chronic use of opioids
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 | NL44645.018.13 |