specifieke aandoeningen zijn niet van belang voor het onderzoek N.A.
Conditions
Interventions
extra non-invasive monitoring of Entropie and SPI to measure adequacy of
analgesia
Sponsors
GE Healthcare Attn: Petra Peltola, Clinical Research Manager
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| • Incidence of hemodynamic instability including hypertension, hypotension, tachycardia and bradycardia • Incidence of subject movements including somatic arousal, somatic response | — |
Secondary
| Measure | Time frame |
|---|---|
| • 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 | — |
Countries
Netherlands
Outcome results
None listed