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

No results posted yet for this 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.

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07232251 on ClinicalTrials.gov