Evaluation of the Effects of Different Intraoperative Warming Techniques on Core Body Temperature and Hematologic Inflammatory Indices (SII, NLR, PLR, LMR) in Patients Undergoing Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Postoperative Core Body Temperature
研究概览
简要总结
Perioperative hypothermia is a frequent and preventable complication that may cause adverse outcomes such as increased blood loss, impaired coagulation, and delayed recovery. Various active warming techniques are used to maintain normothermia during anesthesia; however, their comparative effects on systemic inflammatory responses remain unclear.
This randomized controlled clinical trial aims to evaluate the effects of different intraoperative warming methods on hematologic inflammatory indices - including neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII) - in patients undergoing elective laparoscopic cholecystectomy under general anesthesia.
A total of eligible adult patients will be randomly assigned into four groups according to the intraoperative warming method applied:
Control Group: No active warming applied.
Forced-Air Warming (FAW) Group: Warming blanket system used throughout surgery.
Fluid Warming (FW) Group: Intravenous fluids warmed to maintain normothermia.
Combined Warming (FAW + FW) Group: Both forced-air and fluid warming applied simultaneously.
Core body temperature and perioperative data will be recorded. Venous blood samples will be obtained preoperatively and 24 hours postoperatively to calculate inflammatory indices.
The primary objective is to determine whether active intraoperative warming techniques modulate postoperative inflammatory markers compared to no warming. Secondary outcomes include intraoperative temperature trends, recovery times, and the incidence of hypothermia-related complications.
The results are expected to identify the most effective warming strategy to minimize inflammation and optimize postoperative recovery in laparoscopic procedures.
详细描述
Unintended perioperative hypothermia (core temperature <36°C) commonly occurs during laparoscopic surgeries due to anesthesia-induced thermoregulatory impairment, pneumoperitoneum, and cold ambient conditions. Even mild decreases in body temperature can impair coagulation, delay drug metabolism, and alter immune function. Maintaining normothermia is therefore critical for improving surgical outcomes.
While both forced-air warming systems and fluid warming devices are routinely used, limited data exist comparing their individual and combined effects on postoperative inflammatory responses. Hematologic inflammatory indices such as NLR, PLR, and SII provide cost-effective and reproducible markers that reflect systemic inflammation and immune balance.
This prospective, randomized, controlled, parallel-group study will be conducted at Atatürk University Faculty of Medicine, Department of Anesthesiology and Reanimation.
Eligible participants are adult patients (aged 18-65 years, ASA I-II) scheduled for elective laparoscopic cholecystectomy under general anesthesia. Patients with infection, chronic inflammatory disease, hematologic disorder, or those converted to open surgery will be excluded.
Participants will be randomly assigned to one of four groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective laparoscopic cholecystectomy.
- •ASA (American Society of Anesthesiologists) physical status I-III.
- •Age between 18 and 65 years.
- •Willingness and ability to provide written informed consent.
排除标准
- •ASA IV-V patients.
- •Emergency surgery requirement.
- •Preoperative fever (>38.0 °C) or hypothermia (<36.0 °C).
- •Operation duration <60 minutes or >180 minutes.
- •Endocrine/metabolic disorders affecting body temperature (e.g., moderate-severe thyroid dysfunction, pheochromocytoma, severe dysautonomia, malnutrition).
- •Active infection/sepsis or systemic infection within past 2 weeks.
- •Chronic immunosuppressive therapy (e.g., ≥10 mg/day prednisolone equivalent ≥2 weeks or biological agents in the past month).
- •Hematologic disorders (e.g., leukemia, aplastic anemia, myeloproliferative disorders) or abnormal blood counts (platelet <100 ×10⁹/L, leukocyte <3 ×10⁹/L).
- •Active malignancy or ongoing chemotherapy/radiotherapy in last 3 months.
- •Severe organ failure (Child-Pugh C liver, eGFR <30 mL/min/1.73 m² or dialysis, NYHA III-IV heart failure, GOLD III-IV COPD).
- •Coagulopathy or uncontrolled antithrombotic therapy.
- •Pregnancy or lactation.
- •Conversion from laparoscopic to open surgery.
- •Non-adherence to assigned warming protocol.
- •Inability to place esophageal temperature probe or unreliable temperature monitoring.
- •Intraoperative hemodynamic instability requiring prolonged vasopressor support or blood transfusion.
- •Missing or incomplete preoperative or postoperative CBC preventing calculation of inflammatory indices.
- •Withdrawal of consent or loss to follow-up.
研究组 & 干预措施
Control Group
Patients receive standard intraoperative warming with 38 °C set active warming blanket. Surgical field outside the blanket is covered with passive drapes. No additional warming interventions are applied. (standart care)
干预措施: Standard Active Warming Blanket (Device)
Intravenous Warmer Group
All standard procedures performed in the control group are followed. Additionally, all intravenous fluids administered during the operation are warmed to 38°C with a fluid warmer.
干预措施: Standard Active Warming Blanket (Device)
Intravenous Warmer Group
All standard procedures performed in the control group are followed. Additionally, all intravenous fluids administered during the operation are warmed to 38°C with a fluid warmer.
干预措施: Intravenous Warmer Group (Device)
External Warmer Group
All standard approaches used in the control group are performed. Additionally, a special drape is placed over the upper extremities and thorax, which is connected to a 3M Bair Hugger 700 Series device and warmed to 38°C.
干预措施: Standard Active Warming Blanket (Device)
External Warmer Group
All standard approaches used in the control group are performed. Additionally, a special drape is placed over the upper extremities and thorax, which is connected to a 3M Bair Hugger 700 Series device and warmed to 38°C.
干预措施: External Warmer Group (Device)
Combined Warming Group (Intravenous + External)
All standard approaches used in the control group are performed. Additionally, intravenous fluids are warmed and an external heating device is applied to the upper extremity/thorax.
干预措施: Intravenous Warmer Group (Device)
Combined Warming Group (Intravenous + External)
All standard approaches used in the control group are performed. Additionally, intravenous fluids are warmed and an external heating device is applied to the upper extremity/thorax.
干预措施: Standard Active Warming Blanket (Device)
Combined Warming Group (Intravenous + External)
All standard approaches used in the control group are performed. Additionally, intravenous fluids are warmed and an external heating device is applied to the upper extremity/thorax.
干预措施: External Warmer Group (Device)
结局指标
主要结局
Postoperative Core Body Temperature
时间窗: Intraoperative, measured continuously and recorded at the end of surgery (1 time point)
Core body temperature will be continuously monitored via esophageal probe throughout laparoscopic cholecystectomy. The primary outcome is the mean core temperature at the end of surgery, comparing the four intraoperative warming strategies (Control, IV warming, External warming, Combined IV + External warming).
次要结局
- Systemic Immune-Inflammation Index (SII)(Preoperative baseline, postoperative 1 hour, and postoperative 24 hours)
- Neutrophil-to-Lymphocyte Ratio (NLR)(Preoperative baseline, postoperative 1 hour, and postoperative 24 hours)
- Platelet-to-Lymphocyte Ratio (PLR)(Preoperative baseline, postoperative 1 hour, and postoperative 24 hours)
- Lymphocyte-to-Monocyte Ratio (LMR)(Preoperative baseline, postoperative 1 hour, and postoperative 24 hours)
研究者
Erkan Cem ÇELİK
Principal Investigator
Ataturk University