Intranasal Dexmedetomidine or Esketamine for Negative Postoperative Behavioral Changes in Children (PEDI-NPOBCs)
Exploring the Association of Perioperative Electroencephalographic Changes Following Preoperative Intranasal Dexmedetomidine or Esketamine With Negative Postoperative Behavioral Changes in Children Undergoing Day Surgery
The goal of this clinical trial is to learn whether intranasal dexmedetomidine or esketamine given before anesthesia can reduce negative postoperative behavioral changes in children undergoing day surgery. Negative postoperative behavioral changes may include anxiety, sleep problems, nightmares, irritability, or other unusual behaviors after surgery. This study will also examine whether changes in brain wave patterns during the perioperative period are related to these behavioral changes.
The main questions this study aims to answer are:
Does intranasal dexmedetomidine reduce negative postoperative behavioral changes in children after day surgery? Does intranasal esketamine reduce negative postoperative behavioral changes in children after day surgery? Are perioperative electroencephalographic (EEG) features associated with negative postoperative behavioral changes? Researchers will compare intranasal dexmedetomidine, intranasal esketamine, and normal saline to see whether these treatments differ in their effects on postoperative behavior and perioperative EEG features.
Participants will be randomly assigned to receive intranasal dexmedetomidine, intranasal esketamine, or intranasal normal saline about 30 minutes before anesthesia. They will receive routine perioperative monitoring, including EEG monitoring during surgery and recovery. They will also be assessed for sedation, pain, and emergence delirium. Follow-up assessments of postoperative behavioral changes will be completed on postoperative days 3, 7, and 28.
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Detaillierte Beschreibung
This multicenter, prospective, randomized, double-blind, controlled clinical trial will evaluate whether preoperative intranasal dexmedetomidine or esketamine can reduce negative postoperative behavioral changes in children undergoing day surgery under general anesthesia. The study will also explore whether perioperative electroencephalographic (EEG) features are associated with these behavioral changes and may help explain the effects of the study drugs.
A total of 342 children undergoing elective day surgery will be enrolled across four centers. Eligible participants will be randomly assigned in a 1:1:1 ratio to receive intranasal dexmedetomidine 2.0 micrograms/kg, intranasal esketamine 1.0 mg/kg, or an equal volume of normal saline approximately 30 minutes before induction of anesthesia. Study medications will be prepared in identical, unlabeled nasal spray devices to maintain blinding. Participants, investigators, and outcome assessors will remain unaware of treatment assignment throughout the study.
After study drug administration, participants will undergo routine perioperative monitoring. Sedation will be assessed before surgery. During anesthesia and recovery, EEG and other perioperative clinical data will be collected. Postoperative assessments will include pain and emergence delirium. Negative postoperative behavioral changes will be evaluated on postoperative days 3, 7, and 28. The primary outcome is the incidence of negative postoperative behavioral changes on postoperative day 7. Secondary analyses will assess behavioral outcomes at postoperative days 3 and 28 and examine the relationship between perioperative EEG patterns and postoperative behavioral changes.
This study is designed to provide evidence on the comparative effects of intranasal dexmedetomidine and esketamine on postoperative behavioral recovery in children undergoing day surgery and to identify perioperative EEG markers that may be associated with adverse behavioral outcomes.
Studientyp
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Phase 4
Kontakte und Standorte
Studienkontakt
Studienkontakt
- Name: Li Zhang, Doctoral degree
- Telefonnummer: +86 138 1540 6629
- E-Mail: drzhangli@njmu.edu.cn
Studieren Sie die Kontaktsicherung
- Name: Fei Sun, Master's degree
- Telefonnummer: +86 181 0061 9994
- E-Mail: drsunfei89@163.com
Studienorte
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Jiangsu
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Nanjing, Jiangsu, China, 210008
- Children's Hospital of Nanjing Medical University
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Kontakt:
- Medical Ethics Committee of Children's Hospital of Nanjing Med
- Telefonnummer: +86 189 5176 2937
- E-Mail: drsunfei@njmu.edu.cn
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Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Children aged 2 to 12 years.
- Scheduled to undergo elective day surgery under general anesthesia.
- ASA (American Society of Anesthesiologists) physical status I to III.
Exclusion Criteria:
- Congenital diseases or severe liver or kidney dysfunction.
- History of allergic reactions to study drugs.
- Neuromuscular diseases, cerebral palsy, epilepsy.
- Other psychiatric or neurological disorders.
- Body mass index (BMI) ≥ 30 kg/m².
- Severe upper respiratory tract infections prior to surgery.
- Use of sedatives or analgesics within 48 hours before surgery.
- Exposure to major life stressors within 1 month before surgery (e.g., family separation, death of a parent).
- Refusal to participate or failure to obtain consent from the child's legal guardian.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
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Experimental: Intranasal Dexmedetomidine
Participants receive intranasal dexmedetomidine 2.0 micrograms/kg approximately 30 minutes before induction of general anesthesia.
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Intranasal dexmedetomidine 2.0 micrograms/kg administered once approximately 30 minutes before induction of general anesthesia.
Andere Namen:
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Experimental: Intranasal Esketamine
Participants receive intranasal esketamine 1.0 mg/kg approximately 30 minutes before induction of general anesthesia.
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Intranasal esketamine 1.0 mg/kg administered once approximately 30 minutes before induction of general anesthesia.
Andere Namen:
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Placebo-Komparator: Normal Saline Control
Participants receive an equal volume of intranasal normal saline approximately 30 minutes before induction of general anesthesia.
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Intranasal normal saline of equal volume administered once approximately 30 minutes before induction of general anesthesia.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Incidence of Negative Postoperative Behavioral Changes on Postoperative Day 7
Zeitfenster: Postoperative Day 7
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Incidence of negative postoperative behavioral changes assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
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Postoperative Day 7
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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Incidence of Negative Postoperative Behavioral Changes on Postoperative Day 3
Zeitfenster: Postoperative Day 3
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Incidence of negative postoperative behavioral changes assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
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Postoperative Day 3
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Incidence of Negative Postoperative Behavioral Changes on Postoperative Day 28
Zeitfenster: Postoperative Day 28
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Incidence of negative postoperative behavioral changes assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
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Postoperative Day 28
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Andere Ergebnismessungen
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Sedation Score 30 Minutes After Study Drug Administration
Zeitfenster: 30 minutes after study drug administration
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Sedation level assessed 30 minutes after study drug administration using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale.
Scores range from 0 to 5, with 0 indicating no response to painful stimulus and 5 indicating fully alert.
Higher scores indicate better alertness and less sedation.
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30 minutes after study drug administration
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Postoperative Pain Score
Zeitfenster: At the time of emergence in the post-anesthesia care unit
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Pain intensity assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale.
Scores range from 0 to 10, with higher scores indicating worse pain.
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At the time of emergence in the post-anesthesia care unit
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Emergence Delirium Score
Zeitfenster: After emergence in the post-anesthesia care unit
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Emergence delirium assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale.
Scores range from 0 to 20, with higher scores indicating worse emergence delirium.
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After emergence in the post-anesthesia care unit
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Intraoperative Electroencephalographic Parameters Before Emergence Description
Zeitfenster: From induction of anesthesia until before emergence
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Electroencephalographic parameters derived from raw intraoperative electroencephalography recordings obtained from after induction of anesthesia until before emergence.
Reported values will be summarized from the recorded electroencephalographic data.
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From induction of anesthesia until before emergence
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Incidence of Perioperative Adverse Events
Zeitfenster: From administration of study drug until discharge from the post-anesthesia care unit, assessed up to the maximum expected PACU stay (varies by individual, typically 1-4 hours)
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Incidence of perioperative adverse events, including nausea, vomiting, allergic reactions, emergence delirium, and other adverse behavioral or physiological events occurring in children during the immediate postoperative period.
All adverse events are continuously monitored and recorded by trained clinical staff using standardized observation procedures and behavioral scales (e.g., PAED scale for emergence delirium).
The observation period includes the entire post-anesthesia care unit stay until the child meets discharge criteria.
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From administration of study drug until discharge from the post-anesthesia care unit, assessed up to the maximum expected PACU stay (varies by individual, typically 1-4 hours)
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Emergence Time
Zeitfenster: In the post-anesthesia care unit on the day of surgery
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Time from discontinuation of anesthesia to emergence.
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In the post-anesthesia care unit on the day of surgery
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Postoperative Time to Discharge
Zeitfenster: From end of surgery to discharge on the day of surgery
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Time from the end of surgery to hospital discharge.
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From end of surgery to discharge on the day of surgery
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Parental Satisfaction Score Assessed by the Pediatric Anesthesia Parent Satisfaction (PAPS) Questionnaire
Zeitfenster: On the day of surgery before discharge
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Parental satisfaction with perioperative management assessed on the day of surgery before discharge using the Pediatric Anesthesia Parent Satisfaction (PAPS) questionnaire.
The questionnaire includes 15 items, and total scores range from 15 to 75, calculated as the sum of all item scores.
Higher scores indicate greater parental satisfaction.
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On the day of surgery before discharge
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Mitarbeiter und Ermittler
Sponsor
Sponsor
Mitarbeiter
Mitarbeiter
Ermittler
Ermittler
- Hauptermittler: fei sun, Master's, Children's Hospital of Nanjing Medical University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Neurologische Manifestationen
- Erkrankungen des Nervensystems
- Postoperative Komplikationen
- Pathologische Prozesse
- Verwirrtheit
- Neurobehaviorale Manifestationen
- Neurokognitive Störungen
- Delirium
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Entstehung Delirium
- Psychische Störungen
- Heterocyclische Verbindungen, 1-Ring
- Heterocyclische Verbindungen
- Pharmazeutische Präparate
- Azolen
- Imidazoles
- Anorganische Chemikalien
- Chlorverbindungen
- Kristalloidlösungen
- Isotonische Lösungen
- Lösungen
- Natriumverbindungen
- Chloride
- Salzsäure
- Esketamin
- Dexmedetomidin
- Salzlösung
- Natriumchlorid
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- 202512066-2
- SWYY2025002065 (Andere Zuschuss-/Finanzierungsnummer: ISEFC, China)
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
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