Ireland
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Recruiting Not applicable

Effects of Intraoperative Warming Methods on Hematologic Inflammatory Indices in Laparoscopic Cholecystectomy

NCT07232251 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-12-01
Last updated
2026-10-06

Condition(s) studied

Inflammatory ResponsePerioperative HypothermiaLaparoscopic CholecystectomySurgical Stress Response

Investigational drug(s) / intervention(s)

Standard Active Warming BlanketIntravenous Warmer GroupExternal Warmer Group

Standard Active Warming Blanket: An active blanket set at 38°C is used to maintain the patient's body temperature throughout the operation. Body areas outside the surgical field are covered with passive drapes. No supplemental heating is used.

Intravenous Warmer Group: All intravenous fluids administered during the operation are administered via a fluid warming device at 38°C. All standard practices continue in the control group.

External Warmer Group: A special drape is placed over the upper extremities and thorax, and the patient is connected to an external warm air device at 38°C throughout the operation. All standard practices continue in the control group.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Postoperative Core Body Temperature — 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).

Trial sites (1)

FacilityCityRegionStatus
Ataturk University Erzurum Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07232251 on ClinicalTrials.gov ↗ ← All trials in Turkey