Effect of a Low-Dose Ketamine-Dexmedetomidine-Based Opioid-Sparing Anesthesia Protocol on Postoperative Quality of Recovery After Percutaneous Nephrolithotomy

NCT07855068 | Not Yet Recruiting Phase 4

• 1 other identifier: Ketamine-Dex Recovery in PCNL
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Nephrolithiasis; Postoperative Pain; Quality of Recovery

Keywords

Percutaneous Nephrolithotomy; Opioid-Sparing Anesthesia; Ketamine; Dexmedetomidine; QoR-15; Multimodal General Anesthesia; Postoperative Analgesia

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours postoperatively

Study Arms (2)

Conventional Opioid-Based General Anesthesia

ACTIVE COMPARATOR

Participants receive standard general anesthesia induced with IV propofol, muscle relaxation maintained with IV cisatracurium, and anesthesia maintained with sevoflurane. Systemic analgesia is provided with IV fentanyl 2 µg/kg before induction, followed by 0.5 µg/kg IV boluses as clinically indicated by hemodynamic response. Postoperatively, all patients receive IV paracetamol 1 g every 8 hours, with IV nalbuphine 0.1 mg/kg available every 4 hours as rescue analgesia for NRS pain scores ≥ 4 (maximum single dose 20 mg).

Drug: Fentanyl

Ketamine-Dexmedetomidine Opioid-Sparing Anesthesia

EXPERIMENTAL

Participants receive opioid-sparing general anesthesia induced with IV propofol, muscle relaxation maintained with IV cisatracurium, and anesthesia maintained with sevoflurane. Analgesic maintenance is provided with an IV ketamine bolus of 0.25 mg/kg followed by a continuous infusion of 0.25 mg/kg/h, combined with an IV dexmedetomidine loading dose of 0.5 µg/kg over 10 minutes followed by an infusion of 0.3 µg/kg/h. Postoperatively, all patients receive IV paracetamol 1 g every 8 hours, with IV nalbuphine 0.1 mg/kg available every 4 hours as rescue analgesia for NRS pain scores ≥ 4 (maximum single dose 20 mg).

Drug: Ketamine and Dexmedetomidine

Interventions

Ketamine and Dexmedetomidine DRUG

Intravenous 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.

Ketamine-Dexmedetomidine Opioid-Sparing Anesthesia

Fentanyl DRUG

Intravenous 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.

Conventional Opioid-Based General Anesthesia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Ability to understand and complete the Quality of Recovery-15 (QoR-15) questionnaire.
• Signed written informed consent.

You may not qualify if:

• Patient refusal to participate.
• Known allergy or contraindication to ketamine, dexmedetomidine, fentanyl, or other study medications.
• Significant cardiovascular disease.
• Uncontrolled hypertension.
• Clinically significant bradycardia.
• Severe hepatic or renal impairment.
• Psychiatric illness or active psychosis.
• Chronic opioid use.
• Chronic pain syndromes requiring regular analgesics.
• Pregnancy.
• Conversion to open surgery.
• Inability to complete postoperative assessments.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Nephrolithiasis; Pain, Postoperative

Interventions

Ketamine; Dexmedetomidine; Fentanyl

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 27, 2026
• First Posted: October 2, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09