Quality of Recovery-15 After Opioid-free Versus Opioid-based General Anesthesia in Major Urological Surgery

NCT07665463 | Not Yet Recruiting DMC

• 1 other identifier: 1072.6120.136.2023 QoR-15
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial evaluates postoperative quality of recovery assessed with the Quality of Recovery-15 questionnaire in adult patients undergoing elective major urological surgery under opioid-free versus opioid-based general anesthesia. Opioid-free anesthesia is a multimodal anesthetic technique that avoids intraoperative opioids by combining non-opioid analgesic and sympatholytic agents such as dexmedetomidine, ketamine, lidocaine, non-steroidal anti-inflammatory drugs, and regional analgesia. Opioid-based general anesthesia in this trial includes intraoperative remifentanil infusion. Participants will undergo elective urological surgery, including laparoscopic nephrectomy, robotic nephrectomy, laparoscopic prostatectomy, robotic prostatectomy, laparoscopic cystectomy, or robotic cystectomy. The primary objective is to compare patient-reported quality of recovery between the opioid-free anesthesia group and the remifentanil-based anesthesia group using the Quality of Recovery-15 questionnaire. QoR-15 will be assessed before surgery and on postoperative day 7. Secondary objectives include total postoperative oxycodone dose administered via patient-controlled analgesia during the first 24 hours after surgery, postoperative pain intensity measured using the Numeric Rating Scale at 1, 2, 6, 12, and 24 hours after surgery, incidence of postoperative nausea and vomiting, change in serum creatinine from baseline to postoperative day 1, change in white blood cell count from baseline to postoperative day 1, and the ratio of demanded to delivered PCA boluses. Pre-specified subgroup analyses will compare outcomes according to surgical procedure type: laparoscopic nephrectomy, robotic nephrectomy, laparoscopic prostatectomy, robotic prostatectomy, laparoscopic cystectomy, and robotic cystectomy. Subgroup-by-treatment interaction tests will be performed. Planned enrollment is approximately 600 patients, with 300 patients per treatment arm. The primary patient-reported recovery endpoint will be assessed on postoperative day 7, while analgesic, pain, and early postoperative safety outcomes will be assessed during the first 24 hours after surgery.

Conditions

Postoperative Recovery; Anesthesia, General; Analgesics, Opioid; Urologic Surgical Procedure

Keywords

Quality of Recovery-15; QoR-15; Opioid-free anesthesia; Remifentanil; Urological surgery

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery-15 score on postoperative day 7

  Patient-reported quality of postoperative recovery assessed using the Quality of Recovery-15 questionnaire on postoperative day 7. The total QoR-15 score will be compared between the opioid-free general anesthesia group and the remifentanil-based general anesthesia group.

  7 days

Secondary Outcomes (3)

• Total postoperative oxycodone dose administered via PCA

  1 day

• Postoperative pain intensity assessed using the Numeric Rating Scale

  1 day

• Postoperative nausea and vomiting

  1 day

Study Arms (2)

Opioid-based general anesthesia with remifentanil

ACTIVE COMPARATOR

Participants assigned to this arm will receive opioid-based general anesthesia with intraoperative remifentanil infusion. Premedication includes dexamethasone, paracetamol, metamizole, magnesium sulfate, and ibuprofen. Anesthesia induction will be performed with propofol and rocuronium under train-of-four monitoring. Maintenance of anesthesia will be provided with sevoflurane titrated to minimum alveolar concentration. Intraoperative analgesia will be provided by remifentanil infusion, and the total intraoperative remifentanil dose will be recorded. Procedure-specific regional analgesia will include bilateral erector spinae plane block for nephrectomy, and continuous epidural ropivacaine infusion for cystectomy. Postoperative analgesia will include oxycodone patient-controlled analgesia with 2 mg boluses, a 10-minute lockout interval, and no background infusion, together with paracetamol and metamizole.

Drug: Remifentanil-based general anesthesia

Opioid-free general anesthesia

EXPERIMENTAL

Participants assigned to this arm will receive opioid-free general anesthesia. Premedication includes dexamethasone, paracetamol, metamizole, magnesium sulfate, ibuprofen, and dexmedetomidine. Anesthesia induction will be performed with propofol, ketamine, and rocuronium under train-of-four monitoring. Maintenance of anesthesia will be provided with sevoflurane titrated to minimum alveolar concentration. Intraoperative analgesia and sympatholysis will be provided by continuous dexmedetomidine, ketamine, and lidocaine infusion, with rescue treatment for tachycardia or hypertension according to the study protocol. Procedure-specific regional analgesia will include bilateral erector spinae plane block for nephrectomy, bilateral quadratus lumborum block for prostatectomy, and continuous epidural ropivacaine infusion for cystectomy. Postoperative analgesia will include oxycodone patient-controlled analgesia with 2 mg boluses, a 10-minute lockout interval, and no background infusion, to

Drug: Opioid-free general anesthesia

Interventions

Opioid-free general anesthesia DRUG

General anesthesia without intraoperative opioids using dexmedetomidine, ketamine, lidocaine, sevoflurane, non-opioid co-analgesics, procedure-specific regional analgesia, and standardized postoperative analgesia with oxycodone patient-controlled analgesia.

Opioid-free general anesthesia

Remifentanil-based general anesthesia DRUG

General anesthesia with intraoperative remifentanil infusion, sevoflurane maintenance, non-opioid co-analgesics, procedure-specific regional analgesia, and standardized postoperative analgesia with oxycodone patient-controlled analgesia.

Opioid-based general anesthesia with remifentanil

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 75 years.
• Scheduled for elective major urological surgery under general anesthesia, including laparoscopic or robotic nephrectomy, laparoscopic or robotic prostatectomy, or laparoscopic or robotic cystectomy.
• Ability to operate a patient-controlled analgesia pump postoperatively.
• Ability to understand and use the Numeric Rating Scale for pain assessment.
• Ability to understand and complete the Quality of Recovery-15 questionnaire.
• Written informed consent.

You may not qualify if:

• Patient refusal to participate.
• Inability to operate the patient-controlled analgesia pump.
• Inability to understand the Numeric Rating Scale for pain assessment.
• Inability to understand or complete the Quality of Recovery-15 questionnaire.
• Known hypersensitivity to any of the study drugs, including anesthetics, ketamine, dexmedetomidine, lidocaine, ropivacaine, oxycodone, metamizole, paracetamol, or ibuprofen.
• Second- or third-degree atrioventricular block.
• Symptomatic bradycardia.
• Chronic opioid use.
• Contraindication to the planned regional anesthesia technique, including coagulopathy, therapeutic anticoagulation, or infection at the puncture site.

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University

Cracow, Lesser Poland Voivodeship, 30-688, Poland

Location

Central Study Contacts

Tomasz Skladzien, MD PHD

CONTACT

12 400 18 00; tomasz.skladzien@uj.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Model Details: articipants will be randomly assigned to one of two parallel treatment arms: opioid-free general anesthesia or opioid-based general anesthesia with intraoperative remifentanil.

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will become available after completion of the study and publication of the primary results, anticipated in 2026, and will remain available for 1 year.
• Access Criteria: Data will be made available to qualified researchers upon reasonable request for scientific purposes, after approval by the principal investigator and, where required, by the relevant ethics committee. Data will be shared in de-identified form.

Locations

PL (1)