Effects of Intraoperative Warming Methods on Hematologic Inflammatory Indices in Laparoscopic Cholecystectomy
NCT07232251 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128
Last updated 2025-11-19
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.
Conditions
- Inflammatory Response
- Perioperative Hypothermia
- Laparoscopic Cholecystectomy
- Surgical Stress Response
Interventions
- DEVICE
-
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.
- DEVICE
-
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.
- DEVICE
-
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.
Sponsors & Collaborators
-
Ataturk University
lead OTHER
Principal Investigators
-
Erkan Cem Çelik, doctor · Ataturk University Department of Anesthesiology and Reanimation
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-01
- Primary Completion
- 2026-04-01
- Completion
- 2026-04-02
Countries
- Turkey (Türkiye)
Study Locations
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