Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-24 @ 11:47 PM
NCT ID:
NCT07232251
Eligibility Criteria:
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 blood transfusion.
* Missing or incomplete preoperative or postoperative CBC preventing calculation of inflammatory indices.
* Withdrawal of consent or loss to follow-up.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07232251
Study Brief:
Protocol Section:
NCT07232251