Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-25 @ 9:41 PM
Study NCT ID:
NCT07232251
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Intraoperative Warming Methods on Hematologic Inflammatory Indices in Laparoscopic Cholecystectomy
Sponsor:
Ataturk University
Organization:
Study Overview
Official Title:
Evaluation of the Effects of Different Intraoperative Warming Techniques on Core Body Temperature and Hematologic Inflammatory Indices (SII, NLR, PLR, LMR) in Patients Undergoing Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WARM-CHOL
Brief 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.
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.
Detailed Description:
Unintended perioperative hypothermia (core temperature \<36°C) commonly occurs during laparoscopic surgeries due to anesthesia-induced thermoregulatory impairment, pneumoperitoneum, and cold ambient conditions. Even mild decreases in body temperature can impair coagulation, delay drug metabolism, and alter immune function. Maintaining normothermia is therefore critical for improving surgical outcomes.
While both forced-air warming systems and fluid warming devices are routinely used, limited data exist comparing their individual and combined effects on postoperative inflammatory responses. Hematologic inflammatory indices such as NLR, PLR, and SII provide cost-effective and reproducible markers that reflect systemic inflammation and immune balance.
This prospective, randomized, controlled, parallel-group study will be conducted at Atatürk University Faculty of Medicine, Department of Anesthesiology and Reanimation.
Eligible participants are adult patients (aged 18-65 years, ASA I-II) scheduled for elective laparoscopic cholecystectomy under general anesthesia. Patients with infection, chronic inflammatory disease, hematologic disorder, or those converted to open surgery will be excluded.
Participants will be randomly assigned to one of four groups:
Group C (Control): No active warming; standard passive insulation only.
Group FAW (Forced-Air Warming): Forced-air warming blanket applied from induction until the end of surgery.
Group FW (Fluid Warming): Intravenous fluids administered through a warming device.
Group CF (Combined Warming): Both forced-air warming and fluid warming used together.
Standardized anesthesia induction and maintenance protocols will be followed for all patients. Core temperature will be continuously monitored via nasopharyngeal probe. Temperature, hemodynamic parameters, and perioperative variables will be recorded at fixed intervals.
Blood samples will be obtained at two time points - preoperatively and at 24 hours postoperatively - for complete blood count analysis. The inflammatory indices (NLR, PLR, SII) will be calculated and compared among groups.
Primary Outcome:
Postoperative change in hematologic inflammatory indices \[(neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII)\].
Secondary Outcomes:
Intraoperative temperature maintenance, recovery characteristics, and hypothermia-related adverse events.
Statistical analyses will be performed using SPSS. Continuous variables will be expressed as mean ± SD or median (IQR) and analyzed using ANOVA or Kruskal-Wallis test, as appropriate. Categorical data will be compared using Chi-square or Fisher's exact test. A p-value \<0.05 will be considered statistically significant.
This study seeks to clarify whether intraoperative thermal management strategies influence the systemic inflammatory response, potentially guiding clinicians toward the most effective warming method to enhance recovery and minimize postoperative complications.
While both forced-air warming systems and fluid warming devices are routinely used, limited data exist comparing their individual and combined effects on postoperative inflammatory responses. Hematologic inflammatory indices such as NLR, PLR, and SII provide cost-effective and reproducible markers that reflect systemic inflammation and immune balance.
This prospective, randomized, controlled, parallel-group study will be conducted at Atatürk University Faculty of Medicine, Department of Anesthesiology and Reanimation.
Eligible participants are adult patients (aged 18-65 years, ASA I-II) scheduled for elective laparoscopic cholecystectomy under general anesthesia. Patients with infection, chronic inflammatory disease, hematologic disorder, or those converted to open surgery will be excluded.
Participants will be randomly assigned to one of four groups:
Group C (Control): No active warming; standard passive insulation only.
Group FAW (Forced-Air Warming): Forced-air warming blanket applied from induction until the end of surgery.
Group FW (Fluid Warming): Intravenous fluids administered through a warming device.
Group CF (Combined Warming): Both forced-air warming and fluid warming used together.
Standardized anesthesia induction and maintenance protocols will be followed for all patients. Core temperature will be continuously monitored via nasopharyngeal probe. Temperature, hemodynamic parameters, and perioperative variables will be recorded at fixed intervals.
Blood samples will be obtained at two time points - preoperatively and at 24 hours postoperatively - for complete blood count analysis. The inflammatory indices (NLR, PLR, SII) will be calculated and compared among groups.
Primary Outcome:
Postoperative change in hematologic inflammatory indices \[(neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII)\].
Secondary Outcomes:
Intraoperative temperature maintenance, recovery characteristics, and hypothermia-related adverse events.
Statistical analyses will be performed using SPSS. Continuous variables will be expressed as mean ± SD or median (IQR) and analyzed using ANOVA or Kruskal-Wallis test, as appropriate. Categorical data will be compared using Chi-square or Fisher's exact test. A p-value \<0.05 will be considered statistically significant.
This study seeks to clarify whether intraoperative thermal management strategies influence the systemic inflammatory response, potentially guiding clinicians toward the most effective warming method to enhance recovery and minimize postoperative complications.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2025/2 | OTHER | Atatürk University Clinical Research Ethics Committee | View |