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"Impact of NOciception Level (NOL) Index Intraoperative Guidance of REmifentanil Administration on Opioid Consumption and QoR in Ambulatory Patients Undergoing LAparoscopic Cholecystectomy."
Sponsor: Svendborg Hospital
Summary
Background: Laparoscopic cholecystectomy is a common surgical procedure which constitutes the standard treatment for symptomatic gallbladder disease. Elective procedures are performed as outpatient surgery due to the minimally invasive technique, fast recovery and low complication rates. However, postoperative pain along with nausea and vomiting remains a common barrier to timely discharge from the post-anaesthesia care unit (1). The nociception level index (NOL) monitor provides a multiparametric measure of intraoperative nociception and may support individualized opioid titration (2-3). This single-center, prospective, single-blinded, randomised controlled trial investigated whether NOL-guided remifentanil administration reduces postoperative opioid consumption and improves early recovery compared with conventional clinician-guided analgesic management. Methods: 120 adult patients scheduled for outpatient laparoscopic cholecystectomy were randomised to NOL-guided or conventional remifentanil titration during general anaesthesia. The NOL monitor quantifies nociception on a 0-100 scale. The intervention group received remifentanil titrated to maintain NOL values between 10-25, whereas remifentanil titration was adjusted according to standard clinical parameters in the control group. Postoperative recovery was assessed using the QoR40-questionnaire. Statistical analyses were performed using the median test, chi-square-test, and correlation analyses, with significance defined as p\<0.05.
Official title: "Impact of NOciception Level (NOL) Index Intraoperative Guidance of REmifentanil Administration on Opioid Consumption and QoR in Ambulatory Patients Undergoing LAparoscopic Cholecystectomy. A Randomized Controlled Trial"
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2023-12-01
Completion Date
2024-09-30
Last Updated
2026-09-14
Healthy Volunteers
No
Conditions
Interventions
Remifentanil titration based on Nociception Level Monitor
Use of a nociception level monitor to guide remifentanil infusion during elective laparoscopic cholecystectomy
Remifetanil guided by vital parameters and clinical assessment
Patients were still connected to the nociception level monitor, but it was covered with af cloth and therefore did not influence the nurses administration of remifentanil. The nurses titrated the remifentanil according to standard clinical parameters.
Locations (1)
Odense University Hospital Svendborg
Svendborg, Region Syddanmark, Denmark