MedPath

The NoLA study

Recruiting
Conditions
analgesia, anesthesia, anaesthesia, peroperative, opioid consumption, nociception, monitoring.analgesie, anesthesie, perioperatief, pijn, nociceptie, opiaat consumptie,
Registration Number
NL-OMON28148
Lead Sponsor
eiden Univeristy Medical Center
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
NameTimeMethod
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
NameTimeMethod
1. Differences in Pk (prediction probability) values of NoL, BIS, HR and MAP for<br>predicting the balance of nociception-anti nociception during the following<br>states<br /><br>• Awake vs. loss of consiousness (LOC)<br /><br>• Anesthesia (after discontinuation of propofol and remifentanil) vs. opening<br>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,<br>respiration and medication use (e.g. opioids and antiemetics) in the recovery<br>room obtained at 15-min interval;<br /><br>5. PACU: time until Aldrete > 9 (readiness for discharge);<br /><br>6. Incidence of memory/awareness.
© Copyright 2025. All Rights Reserved by MedPath