Postoperative Cognitive DysfunctionNCT07192549
Perioperative GDNF as a Predictive Factor for Postoperative Delirium and Adverse Neurological Outcomes in Pediatric Surgery
A study testing Sevoflurane group and Propofol group in people with Postoperative Cognitive Dysfunction and Postoperative Delirium, run by General Hospital of Ningxia Medical University.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Postoperative Delirium
- What is being tested?
- Sevoflurane group and Propofol group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 1 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- (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.
Who cannot join
- (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.
About this study
Official title: Perioperative GDNF as a Predictive Factor for Postoperative Delirium and Adverse Neurological Outcomes in Pediatric Surgery:a Single-center, Prospective, Randomized Controlled Study
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.
Read the 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.
- Being tested
- Sevoflurane group, Propofol group
- Medical subject headings
- Postoperative Cognitive Complications, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane groupDrug
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 groupDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane Group | Experimental | 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. Receives: Drug: Sevoflurane group |
| Propofol Group | Active comparator | Anesthesia was maintained with remifentanil combined with continuous intravenous infusion of propofol at a maintenance dose of 0.5 mg/(kg·h). Receives: Drug: Propofol group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative to postoperative day 1
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.
Measured: Preoperative until the child reaches 5 years of age
Secondary outcomes (3)
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.
Measured: Intraoperative to postoperative day 1
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.
Measured: Intraoperative to postoperative day 1
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.
Measured: Intraoperative to postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192549
- Sponsor's protocol ID
- Hui Wang-2025.9
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative GDNF as a Predictive Factor for Postoperative Delirium and Adverse Neurological Outcomes in Pediatric Surgery:a Single-center, Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07192549
- Acronym / sponsor ID
- Hui Wang-2025.9
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane Group | Experimental | Drug: Sevoflurane groupAnesthesia 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. |
| Propofol Group | Active comparator | Drug: Propofol groupAnesthesia was maintained with remifentanil combined with continuous intravenous infusion of propofol at a maintenance dose of 0.5 mg/(kg·h). |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sevoflurane groupPatients 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. | Drug | Sevoflurane Group |
| Propofol groupPreoperative 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. | Drug | Propofol Group |
Primary outcome
Correlation between Perioperative Inflammatory Factors and Neurotrophic Factor Levels with Postoperative Delirium
Time frame: Preoperative to postoperative day 1
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.
Correlation between Perioperative Inflammatory Factors and Neurotrophic Factor Levels with Neurodevelopmental Outcomes at 5 Years of Age
Time frame: Preoperative until the child reaches 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.
3 secondary outcomes
Correlation between Surgical Type on the Expression of Inflammatory Factors with Neurotrophic Factors
Time frame: Intraoperative to postoperative day 1
Correlation between Surgical Duration on the Expression of Inflammatory Factors with Neurotrophic Factors
Time frame: Intraoperative to postoperative day 1
Collection between Anesthetic Drugs on the Expression of Inflammatory Factors with Neurotrophic Factors
Time frame: Intraoperative to postoperative day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane group and Propofol group in people with Postoperative Cognitive Dysfunction and Postoperative Delirium, run by General Hospital of Ningxia Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between Perioperative Inflammatory Factors and Neurotrophic Factor Levels with Postoperative Delirium (time frame: Preoperative to postoperative day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.