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

NCT06380244 · tracked via the Priya Life Science Poland tracker

Sponsor

Jagiellonian University

Phase

Not applicable

Started

2024-04-29

Last updated

2026-08-26

Condition(s) studied

Analgesics, OpioidAnesthesia, EndotrachealAnesthesia, General

Investigational drug(s) / intervention(s)

anesthesia without opioids

anesthesia without opioids: Opioid free general anesthesia

Study 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

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Adults aged 18-75 years scheduled for elective urological surgery under general anesthesia: laparoscopic or robotic nephrectomy, laparoscopic or robotic prostatectomy, or laparoscopic or robotic cystectomy. * Ability to operate a patient-controlled analgesia (PCA) pump postoperatively. * Ability to understand and use the Numeric Rating Scale (NRS) for pain assessment. * Written informed consent. Exclusion Criteria: * Patient's refusal to participate. * Inability to operate the PCA pump. * Inability to understand the NRS pain scale. * Known hypersensitivity to any of the study drugs (anesthetics, ketamine, dexmedetomidine, ropivacaine, oxycodone, metamizole, paracetamol, ibuprofen). * Second- or third-degree atrioventricular block, or symptomatic bradycardia. * Chronic opioid use. * Contraindication to the planned regional anesthesia technique (e.g. coagulopathy or therapeutic anticoagulation, infection at the puncture site).

Primary outcome measure(s)

Total postoperative oxycodone dose administered via PCA (mg) — 0-24 hours after surgery
Total postoperative oxycodone dose administered via PCA (mg) - Cumulative dose of oxycodone (mg) self-administered via PCA pump during the first 24 hours after surgery, compared between the OFA and remifentanil groups.

Trial sites (1)

Facility	City	Region	Status
Jagiellonian University	Krakow	Lesser Poland Voivodeship	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06380244 on ClinicalTrials.gov ↗ ← All trials in Poland