Not Yet RecruitingNot Applicable

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

Turkey (Türkiye)128 participantsStarted 2025-12-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

What they're measuring

Postoperative Core Body Temperature

Timeframe: Intraoperative, measured continuously and recorded at the end of surgery (1 time point)

Trial details

NCT IDNCT07232251

SponsorAtaturk University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-01

Contact for this trial

Erkan Cem Çelik, Doctor

+90-505-344-21-81 drerkancem@yahoo.com