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

2026年9月27日更新者：Mohamed Osman Mohamed Ibrahim、Assiut University

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.

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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

100

阶段

第四阶段

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年至 60年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：双倍的

手臂数量

武器和干预

参与者组/臂	干预/治疗
有源比较器：Conventional Opioid-Based General Anesthesia 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).	药品：Fentanyl 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.
实验性的：Ketamine-Dexmedetomidine Opioid-Sparing Anesthesia 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).	药品：Ketamine and Dexmedetomidine 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.

参与者组/臂

干预/治疗

有源比较器：Conventional Opioid-Based General Anesthesia

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).

药品：Fentanyl

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.

实验性的：Ketamine-Dexmedetomidine Opioid-Sparing Anesthesia

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).

药品：Ketamine and Dexmedetomidine

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.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Quality of Recovery-15 (QoR-15) Score 大体时间：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.	24 hours postoperatively

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Assiut University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2027年10月1日

研究完成 (估计的)

2027年11月1日

研究注册日期

首次提交

2026年9月27日

首先提交符合 QC 标准的

2026年9月27日

首次发布 (实际的)

2026年10月2日

研究记录更新

最后更新发布 (实际的)

2026年10月2日

上次提交的符合 QC 标准的更新

2026年9月27日

最后验证

2026年9月1日

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