ociceptive-Level (NoL)-guided analgia versus standerd practice during general remifentanil/propofol anesthesia in ASA 1-3 patients
Recruiting
- Conditions
- - Analgesia- Anesthesia- Nociceptive level index - Intraoperative monitoring- Haemodynamics
- Registration Number
- NL-OMON27388
- Lead Sponsor
- Medasense
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
1.Age: 18-80 years;
2.ASA I-II-III
Exclusion Criteria
1.Unable to give written informed consent;
2.Use of epidural analgesia or local anesthesia (eg. transversus abdominal plain block, TAP block)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Opioid and propofol consumption in total dose and dose/min; and <br /><br>2. Incidence (number of episodes) and total duration of inadequate anesthesia
- Secondary Outcome Measures
Name Time Method 1.Differences in Pk (prediction probability) values of NoL, BIS, HR and MAP for predicting the balance of nociception-anti nociception during the following states<br /><br>•Awake vs. loss of consiousness (LOC)<br /><br>•Anesthesia (after discontinuation of propofol and remifentanil) vs. opening eyes<br /><br>•LOC vs intubation<br /><br>•Normal stimulation vs maximum stimulation (as indicated by the surgeon);<br /><br>2.Incidence of NoL values < 10 and > 20; <br /><br>3.Time from reversal of neuromuscular blockade to extubation;<br /><br>4.Pain and sedation scores, incidence of nausea/vomiting, hemodynamics, respiration and medication use (e.g. opioids and antiemetics) in the recovery room obtained at 15-min interval;<br /><br>5.PACU: time until Aldrete > 9 (readiness for discharge);<br /><br>6.Incidence of memory/awareness.<br>