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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-3
SponsorGeneral Hospital of Ningxia Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(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.

Disqualifiers

(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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sevoflurane group

    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

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Sevoflurane GroupExperimental treatment 1 intervention
Group B: Propofol GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Correlation between Perioperative Inflammatory Factors and Neurotrophic Factor Levels with Postoperative Delirium

The levels of inflammatory factors IL-1β, IL-6, and TNF-α in pediatric patients will be measured using ELISA before surgery, 30 minutes during surgery, and one day after surgery. Simultaneously, the levels of neurotrophic factors BDNF and GDNF will be detected using ELISA. The RASS scale was employed to assess the level of emergence agitation in the children. A t-test will be used to compare whether the inflammatory factor levels between the two groups were correlated with the occurrence of emergence agitation, to determine whether the pre- and postoperative changes in neurotrophic factors are statistically significant, and to evaluate whether these changes is correlated with the incidence of emergence agitation.

Time frame
Preoperative to postoperative day 1
2

Correlation between Perioperative Inflammatory Factors and Neurotrophic Factor Levels with Neurodevelopmental Outcomes at 5 Years of Age

The levels of inflammatory factors IL-1β, IL-6, and TNF-α in pediatric patients will be measured using ELISA before surgery, 30 minutes during surgery, and one day after surgery. Simultaneously, the levels of neurotrophic factors BDNF and GDNF will be detected using ELISA. The Wechsler Scale II will be employed to assess the learning and memory abilities of the children at five years of age. A t-test was used to compare whether the inflammatory factor levels between the two groups will be correlated with the development of long-term learning and memory function, and to evaluate whether changes in these levels were associated with the occurrence of long-term learning and memory function.

Time frame
Preoperative until the child reaches 5 years of age

Secondary outcomes

1

Correlation between Surgical Type on the Expression of Inflammatory Factors with Neurotrophic Factors

We will categorize the surgeries into upper abdominal, lower abdominal, and limb procedures based on human anatomical structure. Correlation analysis will performe between these surgical categories and the levels of inflammatory factors and neurotrophic factors measured by ELISA. This analysis aim to evaluate whether the type of surgery will correlate with changes in inflammatory factor levels, as well as to examine the association between surgical categories and the occurrence of postoperative delirium.

Time frame
Intraoperative to postoperative day 1
2

Correlation between Surgical Duration on the Expression of Inflammatory Factors with Neurotrophic Factors

We will classify the surgeries into two categories based on a 2-hour duration threshold and performed correlation analysis with the levels of inflammatory factors and neurotrophic factors measured by ELISA. This analysis aimed to evaluate whether the duration of surgery was correlated with changes in inflammatory factor levels, as well as to examine the association between surgical duration and the occurrence of emergence delirium and long-term neurological function.

Time frame
Intraoperative to postoperative day 1
3

Collection between Anesthetic Drugs on the Expression of Inflammatory Factors with Neurotrophic Factors

We will categorize the surgeries into propofol-based maintenance group and sevoflurane-based maintenance group. Correlation analysis will be performed between these two anesthetic approaches and the levels of inflammatory factors and neurotrophic factors measured by ELISA. This analysis aim to evaluate whether the choice of anesthetic agent was correlated with alterations in inflammatory factor levels.

Time frame
Intraoperative to postoperative day 1

Other outcomes

Locations

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