RecruitingNot ApplicableNCT06380244

Opioid-free Anesthesia as an Alternative to General Anesthesia in Abdominal Surgery


Sponsor

Jagiellonian University

Enrollment

600 participants

Start Date

Apr 29, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Opioid-free anesthesia (OFA) is a multimodal technique that eliminates intraoperative opioids by combining dexmedetomidine, ketamine, lidocaine, NSAIDs, and regional analgesia. Growing evidence suggests OFA reduces postoperative opioid consumption, opioid-related adverse effects, and may have favorable oncological implications in cancer surgery. This randomized controlled trial compares OFA with opioid-based anesthesia (remifentanil) in patients undergoing elective urological surgery: laparoscopic nephrectomy, robotic nephrectomy, laparoscopic prostatectomy, robotic prostatectomy, laparoscopic cystectomy, and robotic cystectomy. The PRIMARY OBJECTIVE is to compare the total postoperative oxycodone dose (mg) administered via patient-controlled analgesia (PCA) during the first 24 hours after surgery between the OFA and remifentanil groups. SECONDARY OBJECTIVES include: postoperative pain intensity (NRS) at 1, 2, 6, 12, and 24 hours; incidence of postoperative nausea and vomiting (PONV); change in serum creatinine from baseline to postoperative day 1; change in white blood cell (WBC) count from baseline to postoperative day 1; and the ratio of demanded to delivered PCA boluses. PRE-SPECIFIED SUBGROUP ANALYSES will compare outcomes by surgical procedure type: laparoscopic nephrectomy, robotic nephrectomy, laparoscopic prostatectomy, robotic prostatectomy, laparoscopic cystectomy, and robotic cystectomy. Subgroup-by-treatment interaction tests will be performed and reported as forest plots. Planned enrollment: approximately 600 patients (300 per arm). Follow-up: 24 hours postoperatively.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying anesthesia without opioids for people with analgesics, opioid, anesthesia general, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERanesthesia without opioids

Opioid free general anesthesia


Locations(1)

Jagiellonian University

Krakow, Lesser Poland Voivodeship, Poland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06380244


Related Trials