About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
ASA IV-V patients.
Emergency surgery requirement.
Preoperative fever (>38.0 °C) or hypothermia (<36.0 °C).
Operation duration <60 minutes or >180 minutes.
Trial design
Parallel
Treatments tested in this trial
Standard Active Warming Blanket
DeviceAn 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
DeviceAll 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
DeviceA 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.
Treatment groups
Trial outcomes
Primary outcomes
Postoperative Core Body Temperature
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).
Secondary outcomes
Systemic Immune-Inflammation Index (SII)
SII will be calculated using neutrophil, lymphocyte, and platelet counts from complete blood counts to assess systemic inflammatory response.
Neutrophil-to-Lymphocyte Ratio (NLR)
NLR will be calculated from complete blood counts to evaluate the balance between acute inflammation and immune function.
Platelet-to-Lymphocyte Ratio (PLR)
PLR will be calculated from platelet and lymphocyte counts to assess postoperative inflammatory and thrombotic response.
Lymphocyte-to-Monocyte Ratio (LMR)
LMR will be calculated from lymphocyte and monocyte counts to evaluate immune regulation and inflammatory balance after surgery.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.