Anesthetic-sparing and Renal Protection Effects of Minimal-flow Sevoflurane Anesthesia and Multimodal Analgesia Using a Mixture of Dexmedetomidine-ketamine-lidocaine in Head and Neck Cancer Patients With Free Flap Microvascular Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Renal function
研究概览
简要总结
This study evaluates the anesthetic-sparing and renal protection effects of minimal-flow sevoflurane anesthesia combined with multimodal analgesia using dexmedetomidine, ketamine, and lidocaine in head and neck cancer patients undergoing free flap microvascular surgery. The 2x2 factorial randomized controlled trial aims to compare sevoflurane usage and renal function changes with different fresh gas flow rates and multimodal analgesia.
详细描述
This study investigates the anesthetic-sparing and renal protection effects of minimal-flow sevoflurane anesthesia combined with a multimodal analgesia strategy using dexmedetomidine, ketamine, and lidocaine in head and neck cancer patients undergoing free flap microvascular surgery. The trial employs a 2x2 factorial randomized controlled design to evaluate the effectiveness of different fresh gas flow rates and multimodal analgesia on sevoflurane usage and renal function.
Background and Significance:
Sevoflurane, a widely used anesthetic for prolonged surgeries, significantly contributes to healthcare-related greenhouse gas emissions. Reducing fresh gas flow during anesthesia effectively minimizes anesthetic usage, but concerns about potential renal damage hinder its clinical application. Recent studies show that sevoflurane enhances renal sympathetic nerve activity, leading to decreased renal blood flow and increased risks of acute kidney injury, particularly when coupled with factors like low blood pressure.
Multi-modal analgesia combining drugs like dexmedetomidine, ketamine, and lidocaine has emerged as a trend in anesthesiology. These drugs not only reduce sevoflurane usage but may also counteract its renal effects. This project aims to investigate the renal protective effects and anesthetic reduction potential of a multi-modal analgesia strategy in head and neck cancer surgeries.
Study Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study employs a triple-blinding approach to ensure unbiased results. The participants, care providers (including anesthesiologists and nurses), and investigators are all blinded to the group assignments. Randomization envelopes containing the treatment allocation will be prepared and sealed by a research assistant who is not involved in patient care or data collection.
At the time of surgery, the envelope will be opened by a designated anesthesia nurse who will prepare the study medication (either the dexmedetomidine-ketamine-lidocaine mixture or normal saline) according to the randomization. The medication will be labeled identically to maintain blinding and administered via continuous infusion during anesthesia. Fresh gas flow settings will be adjusted according to the randomization and indicated by a concealed flow meter display.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-99 years
- •Scheduled for head and neck cancer tumor resection and free flap reconstruction surgery
排除标准
- •Preoperative tracheostomy
- •History of previous head and neck cancer tumor resection
- •Anemia (hematocrit <30% or recent transfusion)
- •Hypertension on ACEI/ARB medications
- •Significant medical conditions (e.g., NYHA class 3 or 4 heart failure, eGFR <60 ml/min/1.73 m², Child B or C liver failure, severe respiratory disorders, pre-existing cognitive impairment)
- •ASA physical status 4 or 5
- •Allergies to sevoflurane, dexmedetomidine, ketamine, or lidocaine
研究组 & 干预措施
Group 1 (HL-D)
Fresh gas flow at 0.5 L/min with dexmedetomidine-ketamine-lidocaine mixture
干预措施: Multimodal analgesia using dexmedetomidine-ketamine-lidocaine mixture (Drug)
Group 1 (HL-D)
Fresh gas flow at 0.5 L/min with dexmedetomidine-ketamine-lidocaine mixture
干预措施: Minimal flow sevoflurane (Device)
Group 2 (HL-ND)
Fresh gas flow at 0.5 L/min with placebo normal saline
干预措施: Minimal flow sevoflurane (Device)
Group 3 (L-D)
Fresh gas flow at 1.0 L/min with dexmedetomidine-ketamine-lidocaine mixture
干预措施: Multimodal analgesia using dexmedetomidine-ketamine-lidocaine mixture (Drug)
结局指标
主要结局
Renal function
时间窗: Perioperative period
Changes in renal function (serum renin, AVP levels, urine KIM-1, NGAL levels)
Sevoflurane usage (mL/h)
时间窗: Intraoperative period
Volatile anesthetic consumption hourly
次要结局
- Postoperative analgesic effect_1(Perioperative period)
- Postoperative analgesic effect_2(Perioperative period)
- Hemodynamic stability_3(Intraoperative period)
- Length of hospital stay(Perioperative period)
- Cognitive function(Perioperative period)
- Acute kidney injury(Perioperative period)
- Hemodynamic stability_1(Intraoperative period)
- Hemodynamic stability_2(Intraoperative period)