Perioperative GDNF as a Predictive Factor for Postoperative Delirium and Adverse Neurological Outcomes in Pediatric Surgery

NCT ID: NCT07192549

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2030-12-01

Brief Summary

To observe the dynamic changes in serum levels of inflammatory cytokines (e.g., IL-6, TNF-α), Brain-Derived Neurotrophic Factor (BDNF), and Glial Cell Line-Derived Neurotrophic Factor (GDNF) during the perioperative period in pediatric patients undergoing Scheduled Laparoscopic Hernia Repair surgery, and to investigate their relationship with the occurrence of postoperative delirium (POD) and postoperative cognitive dysfunction (POCD),and to compare the different influence between propofol and sevoflurane . The aim is to provide insights into the neurobiological mechanisms underlying these complications and to identify potential biomarkers for risk stratification.

Detailed Description

Clarify the Correlation Between Perioperative Changes in Inflammatory Factors, BDNF, and GDNF Levels and Postoperative delirium (POD) Blood and urine samples were collected from pediatric patients at three time points: 5 minutes before anesthesia induction (T0), 1 hour after surgery began (T1), and on the first postoperative day (T2). Serum levels of inflammatory factors (such as IL-6 and TNF-α) as well as brain-derived neurotrophic factor (BDNF) and glial cell line-derived neurotrophic factor (GDNF) were measured. The Richmond Agitation-Sedation Scale (RASS) was used to assess the children within 5-10 minutes after awakening from anesthesia. The RASS score ranges from +4 (combative agitation) to -5 (coma), comprising 10 levels, with higher scores indicating more agitated states and lower scores indicating deeper sedation. A score ≥+1 was defined as agitation. By comparing changes in inflammatory factors and neurotrophic factor levels across different time points, the association with the occurrence of postoperative agitation was analyzed.

Clarify the Correlation Between Perioperative Changes in Inflammatory Factors, BDNF, and GDNF Levels and Learning and Memory Abilities at Age 5 For the same cohort of children, based on blood and urine samples collected at the aforementioned time points (T0, T1, T2), concentrations of inflammatory factors (such as IL-6 and TNF-α), BDNF, and GDNF were measured. When the children reached 5 years of age, standardized neurocognitive assessment tools (such as the Wechsler Preschool and Primary Scale of Intelligence-IV [WPPSI-IV] or age-appropriate memory and learning function tests) were used to evaluate their learning and memory abilities. Statistical analysis was performed to explore the potential correlation between the dynamic changes in the aforementioned biomarkers during the perioperative period and cognitive function scores at age 5.

Conditions

Postoperative Cognitive Dysfunction; Postoperative Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sevoflurane Group

Anesthesia was maintained with sevoflurane (Inhalation Sevoflurane, Brand: Kaiteli, Specification: 120 mL, Approval Number: National Drug Approval H20070172, Manufacturer: Shanghai Hengrui Pharmaceutical) combined with continuous intravenous infusion of remifentanil.

Group Type: EXPERIMENTAL

Sevoflurane group

Intervention Type: DRUG

Patients fasted for 6 hours and abstained from clear fluids for 3 hours preoperatively. Upon entering the operating room, oxygen was administered via an appropriately sized face mask at a flow rate of 6-8 L/min. Anesthesia was induced by sequential intravenous injection of remimazolam, sufentanil, and rocuronium. A laryngeal mask was inserted after the disappearance of the eyelash reflex. Anesthesia was maintained with sevoflurane (Inhalation Sevoflurane, Brand: Kaiteli, Specification: 120 mL, Approval Number: National Drug Approval H20070172, Manufacturer: Shanghai Hengrui Pharmaceutical) combined with continuous intravenous infusion of remifentanil. During surgery, vital signs and body movement responses were closely monitored, and the inhaled concentration of sevoflurane was adjusted as needed (maintained at 1%-3%). Administration of anesthetics was discontinued 5 minutes before the end of surgery.

Propofol Group

Anesthesia was maintained with remifentanil combined with continuous intravenous infusion of propofol at a maintenance dose of 0.5 mg/(kg·h).

Group Type: ACTIVE_COMPARATOR

Propofol group

Intervention Type: DRUG

Preoperative preparation was identical to that of the Sevoflurane Group. Anesthesia induction was performed using the same sequence of intravenous injections of remimazolam, sufentanil, and rocuronium, followed by laryngeal mask insertion after the disappearance of the eyelash reflex. Anesthesia was maintained with remifentanil combined with continuous intravenous infusion of propofol at a maintenance dose of 0.5 mg/(kg·h). The infusion rate was dynamically adjusted based on intraoperative vital signs. Administration of anesthetics was stopped 5 minutes before the end of surgery.

Interventions

Sevoflurane group

Patients fasted for 6 hours and abstained from clear fluids for 3 hours preoperatively. Upon entering the operating room, oxygen was administered via an appropriately sized face mask at a flow rate of 6-8 L/min. Anesthesia was induced by sequential intravenous injection of remimazolam, sufentanil, and rocuronium. A laryngeal mask was inserted after the disappearance of the eyelash reflex. Anesthesia was maintained with sevoflurane (Inhalation Sevoflurane, Brand: Kaiteli, Specification: 120 mL, Approval Number: National Drug Approval H20070172, Manufacturer: Shanghai Hengrui Pharmaceutical) combined with continuous intravenous infusion of remifentanil. During surgery, vital signs and body movement responses were closely monitored, and the inhaled concentration of sevoflurane was adjusted as needed (maintained at 1%-3%). Administration of anesthetics was discontinued 5 minutes before the end of surgery.

Intervention Type: DRUG

Propofol group

Preoperative preparation was identical to that of the Sevoflurane Group. Anesthesia induction was performed using the same sequence of intravenous injections of remimazolam, sufentanil, and rocuronium, followed by laryngeal mask insertion after the disappearance of the eyelash reflex. Anesthesia was maintained with remifentanil combined with continuous intravenous infusion of propofol at a maintenance dose of 0.5 mg/(kg·h). The infusion rate was dynamically adjusted based on intraoperative vital signs. Administration of anesthetics was stopped 5 minutes before the end of surgery.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• (1) Aged 1-3 years; (2) American Society of Anesthesiologists (ASA) Physical Status Classification I-II; (3) Body Mass Index (BMI) 18-35 kg/m²; (4) Agreement to participate in the study and signed informed consent form.

Exclusion Criteria

• (1) Surgical duration exceeding 4 hours; (2) Patients with language or hearing impairments hindering effective communication; (3) Patients with postoperative infections or perioperative cardiopulmonary complications; (4) Patients with preoperative psychiatric disorders.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Ningxia Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Hui Wang-2025.9

Identifier Type: -

Identifier Source: org_study_id