Not Yet RecruitingPhase 4ketamine

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

Sponsored by Assiut University

NCT ID
NCT07855068
Target Enrollment
100 participants
Start Date
2026-10
Est. Completion
2027-11

About This Study

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 Studied

NephrolithiasisPostoperative PainQuality of Recovery

Interventions

  • •Ketamine and Dexmedetomidine
  • •Fentanyl

Eligibility

Age:18 Years - 60 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source