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臨床試験

"Impact of NOciception Level (NOL) Index Intraoperative Guidance of REmifentanil Administration on Opioid Consumption and QoR in Ambulatory Patients Undergoing LAparoscopic Cholecystectomy."

NCT: NCT07810894 · COMPLETED

NCT識別子NCT07810894
ステータスCOMPLETED
開始日2023-12-01
完了2024-09-30
SponsorSvendborg Hospital (OTHER)
First posted
Last updated

概要

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.

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