Effects of Minimal-Flow Sevoflurane and Multimodal Analgesia in Head and Neck Cancer Surgery
- Conditions
- Acute Kidney InjuryAnesthesiaRenal ProtectionMultimodal AnalgesiaHead and Neck Cancer
- Interventions
- Device: Minimal flow sevofluraneDrug: Multimodal analgesia using dexmedetomidine-ketamine-lidocaine mixture
- Registration Number
- NCT06521697
- Lead Sponsor
- National Taiwan University Hospital
- Brief Summary
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.
- Detailed Description
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:
To evaluate the anesthetic-sparing effect of minimal-flow sevoflurane anesthesia (0.5 L/min) combined with dexmedetomidine-ketamine-lidocaine multimodal analgesia.
To assess the renal protection effects of dexmedetomidine-ketamine-lidocaine multimodal analgesia during minimal-flow sevoflurane anesthesia.
To examine the safety and other potential effects (e.g., hemodynamic stability, postoperative cognitive function) of the combined anesthesia strategy.
Methods:
The study will be conducted at National Taiwan University Hospital and will involve adult patients (18-99 years) scheduled for head and neck cancer tumor resection and free flap reconstruction surgery. Patients will be randomized into four groups in a 2x2 factorial design:
Group 1 (HL + D): Fresh gas flow at 0.5 L/min with dexmedetomidine-ketamine-lidocaine mixture.
Group 2 (HL): Fresh gas flow at 0.5 L/min with normal saline. Group 3 (D): Fresh gas flow at 1.0 L/min with dexmedetomidine-ketamine-lidocaine mixture.
Group 4 (Control): Fresh gas flow at 1.0 L/min with normal saline. The dexmedetomidine-ketamine-lidocaine mixture will be continuously infused from the induction of anesthesia until the end of surgery. Fresh gas flow settings will be maintained using the EtControl function of the GE Aisys CS2 anesthesia machine. Anesthetic depth and hemodynamic parameters will be monitored throughout the procedure.
Data Collection:
Primary Outcome Measures: Sevoflurane usage (mL/h) and changes in renal function (serum renin, AVP levels, urine KIM-1, NGAL levels).
Secondary Outcome Measures: Incidence of acute kidney injury, hemodynamic stability, postoperative pain scores, length of hospital stay, and postoperative cognitive function.
Blood and urine samples will be collected at four time points: before anesthesia induction, upon arrival in the ICU, 24 hours post-surgery, and 48 hours post-surgery. Clinical data, including demographic information, surgical details, anesthetic drug usage, hemodynamic parameters, and postoperative outcomes, will also be recorded.
Statistical Analysis:
Data will be analyzed using appropriate statistical methods, including Student's t-test, Mann-Whitney U test, Chi-square test, Fisher's exact test, and multivariate analysis of variance (MANOVA). Statistical significance will be defined as p \< 0.05.
Potential Challenges and Solutions:
Potential challenges include patient recruitment and adherence to protocol. To mitigate these, the study will involve experienced anesthesiologists and research staff who will ensure proper patient selection and protocol compliance.
Expected Outcomes:
The study aims to propose a feasible strategy to mitigate sevoflurane's renal effects, crucial for patients at risk of acute kidney injury. It also seeks to validate that minimal fresh gas flow (0.5 L/min) during sevoflurane anesthesia, coupled with multimodal analgesia, reduces sevoflurane usage, saving costs and contributing to carbon reduction. Additionally, the study will explore the potential protective effects of the multimodal analgesia strategy on other organs during prolonged surgeries.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Age 18-99 years
- Scheduled for head and neck cancer tumor resection and free flap reconstruction surgery
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Group 2 (HL-ND) Minimal flow sevoflurane Fresh gas flow at 0.5 L/min with placebo normal saline Group 1 (HL-D) Minimal flow sevoflurane Fresh gas flow at 0.5 L/min with dexmedetomidine-ketamine-lidocaine mixture Group 3 (L-D) Multimodal analgesia using dexmedetomidine-ketamine-lidocaine mixture Fresh gas flow at 1.0 L/min with dexmedetomidine-ketamine-lidocaine mixture Group 1 (HL-D) Multimodal analgesia using dexmedetomidine-ketamine-lidocaine mixture Fresh gas flow at 0.5 L/min with dexmedetomidine-ketamine-lidocaine mixture
- Primary Outcome Measures
Name Time Method Renal function Perioperative period Changes in renal function (serum renin, AVP levels, urine KIM-1, NGAL levels)
Sevoflurane usage (mL/h) Intraoperative period Volatile anesthetic consumption hourly
- Secondary Outcome Measures
Name Time Method Postoperative analgesic effect_1 Perioperative period Postoperative pain scores (VAS)
Postoperative analgesic effect_2 Perioperative period Postoperative analgesic consumption
Hemodynamic stability_3 Intraoperative period Hemodynamic stability, present as vasoactive drug amount of usage
Length of hospital stay Perioperative period Length of hospital stay after surgery
Cognitive function Perioperative period Incidence of postoperative cognitive dysfunction using Confusion Assessment Method-Intensive Care Unit (CAM-ICU)
Acute kidney injury Perioperative period Incidence of acute kidney injury
Hemodynamic stability_1 Intraoperative period Hemodynamic stability, present as heart rate fluctuation
Hemodynamic stability_2 Intraoperative period Hemodynamic stability, present as blood pressure fluctuation