NephrolithiasisPhase 4NCT07855068
Effect of a Low-Dose Ketamine-Dexmedetomidine-Based Opioid-Sparing Anesthesia Protocol on Postoperative Quality of Recovery After Percutaneous Nephrolithotomy
A Phase 4 study testing Ketamine and Dexmedetomidine and Fentanyl in people with Nephrolithiasis and Postoperative Pain, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nephrolithiasis, Postoperative Pain, Quality of Recovery
- What is being tested?
- Ketamine and Dexmedetomidine and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Psychiatric illness or active psychosis.
- Chronic opioid use.
- Chronic pain syndromes requiring regular analgesics.
- Pregnancy.
- Conversion to open surgery.
- Inability to complete postoperative assessments.
About this study
Official title: Effect of a Low-Dose Ketamine-Dexmedetomidine-Based Opioid-Sparing Anesthesia Protocol on Postoperative Quality of Recovery After Percutaneous Nephrolithotomy: A Randomized Controlled Trial
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.
Read more
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
- Being tested
- Ketamine and Dexmedetomidine, Fentanyl
- Keywords
- Percutaneous Nephrolithotomy, Opioid-Sparing Anesthesia, Ketamine, Dexmedetomidine, QoR-15, Multimodal General Anesthesia, Postoperative Analgesia
- Medical subject headings
- Nephrolithiasis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine and DexmedetomidineDrug
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.
FentanylDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Ketamine and Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Osman Mohamed Ibrahim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855068
- Sponsor's protocol ID
- Ketamine-Dex Recovery in PCNL
- Status last verified
- Sep 2026
- First submitted
- 27 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Low-Dose Ketamine-Dexmedetomidine-Based Opioid-Sparing Anesthesia Protocol on Postoperative Quality of Recovery After Percutaneous Nephrolithotomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07855068
- Acronym / sponsor ID
- Ketamine-Dex Recovery in PCNL
- Conditions
- Nephrolithiasis, Postoperative Pain, Quality of Recovery
- Keywords
- Percutaneous Nephrolithotomy, Opioid-Sparing Anesthesia, Ketamine, Dexmedetomidine, QoR-15, Multimodal General Anesthesia, Postoperative Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Opioid-Based General Anesthesia | Active comparator | Drug: FentanylParticipants 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). |
| Ketamine-Dexmedetomidine Opioid-Sparing Anesthesia | Experimental | Drug: Ketamine and DexmedetomidineParticipants 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- Patient refusal to participate.
- Known allergy or contraindication to ketamine, dexmedetomidine, fentanyl, or other study medications.
- Significant cardiovascular disease.
- Uncontrolled hypertension.
- Clinically significant bradycardia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine and DexmedetomidineIntravenous 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. | Drug | Ketamine-Dexmedetomidine Opioid-Sparing Anesthesia |
| FentanylIntravenous 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. | Drug | Conventional Opioid-Based General Anesthesia |
Primary outcome
Quality of Recovery-15 (QoR-15) Score
Time frame: 24 hours postoperatively
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine and Dexmedetomidine and Fentanyl in people with Nephrolithiasis and Postoperative Pain, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery-15 (QoR-15) Score (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.