Percutaneous nephrolithotomy (PCNL) is a minimally invasive surgical procedure used to remove large or complex kidney stones. Although effective, dilation of the surgical tract and the placement of a nephrostomy tube cause significant postoperative pain. Conventional general anesthesia relies heavily on opioid medications (such as fentanyl) for pain control; however, opioids can cause unwanted side effects, including nausea, vomiting, dizziness, sedation, and delayed bowel recovery.
The purpose of this clinical trial is to investigate whether an opioid-sparing general anesthesia protocol utilizing a combination of low-dose ketamine and dexmedetomidine improves overall postoperative quality of recovery in adult patients undergoing PCNL compared with standard opioid-based anesthesia.
Participants will be randomly assigned to one of two groups:
* Conventional Opioid-Based Group: Participants receive standard general anesthesia supplemented with intravenous fentanyl before induction and as needed during surgery to manage pain. * Ketamine-Dexmedetomidine Group: Participants receive general anesthesia combined with an initial dose and continuous low-dose intravenous infusion of ketamine and dexmedetomidine throughout the surgery.
Following surgery, all participants will receive scheduled intravenous paracetamol, with rescue opioid pain medication (nalbuphine) available if pain levels reach a moderate-to-severe threshold.
The primary outcome of the study is the patient-reported Quality of Recovery-15 (QoR-15) score at 24 hours after surgery. Secondary outcomes include total intraoperative and postoperative opioid consumption, postoperative pain scores at rest and during movement, time to first rescue pain medication, anesthesia emergence and recovery times, incidence of postoperative nausea and vomiting, and potential side effects.
Adult patients scheduled for elective percutaneous nephrolithotomy (PCNL) under general anesthesia.
Age between 18 and 60 years.
American Society of Anesthesiologists (ASA) physical status I or II.
Expected surgical duration ≤ 2 hours.
Patient refusal to participate.
Known allergy or contraindication to ketamine, dexmedetomidine, fentanyl, or other study medications.
Significant cardiovascular disease.
Uncontrolled hypertension.
Parallel
Ketamine and Dexmedetomidine
DrugIntravenous ketamine bolus of 0.25 mg/kg administered before induction, followed by a continuous infusion of 0.25 mg/kg/h. Combined with intravenous dexmedetomidine loading dose of 0.5 µg/kg administered over 10 minutes, followed by a continuous infusion of 0.3 µg/kg/h throughout surgery.
Fentanyl
DrugIntravenous fentanyl administered at a dose of 2 µg/kg before induction, followed by supplementary boluses of 0.5 µg/kg IV as needed according to intraoperative hemodynamic response.
Quality of Recovery-15 (QoR-15) Score
The Quality of Recovery-15 (QoR-15) questionnaire assesses patient-reported recovery across five domains: physical comfort, physical independence, psychological support, pain, and emotional state. The tool consists of 15 items, each scored from 0 to 10, resulting in a total score ranging from 0 to 150. Higher scores represent better postoperative quality of recovery.
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