Elective Laparoscopic Cholecystectomy
Conditions
Keywords
Laparoscopic cholecystectomy, Nociceptive level monitoring, morphine, QoR40, recovery
Brief 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.
Interventions
DEVICERemifentanil titration based on Nociception Level Monitor
Use of a nociception level monitor to guide remifentanil infusion during elective laparoscopic cholecystectomy
OTHERRemifetanil 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.
Sponsors
Svendborg Hospital
Medtronic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Clinical Nurse Specialist who called the patients 2 weeks after surgery
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) class I-III * Patients aged 18 years + * Non-pregnant * Must read and understand Danish * Scheduled for ambulatory elective laparoscopic cholecystectomy
Exclusion criteria
* Inability to give consent * Regular opioid use * Chronic kidney disease (eGFR\<30) * Intolerance to opioids, and surgery converted to open procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine consumption | From arriving in the postanasthesia care unit to discharge from the unit. | Postoperative morphine consumption in the postanasthesia care unit |
Countries
Denmark
Outcome results
None listed