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Intranasal Dexmedetomidine or Esketamine for Negative Postoperative Behavioral Changes in Children (PEDI-NPOBCs)

29 aprile 2026 aggiornato da: Sun Fei, Nanjing Children's Hospital

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

342

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

  • Nome: Fei Sun, Master's degree
  • Numero di telefono: +86 181 0061 9994
  • Email: drsunfei89@163.com

Luoghi di studio

  • Cina
    • Jiangsu
      • Nanjing, Jiangsu, Cina, 210008
        • Children's Hospital of Nanjing Medical University
        • Contatto:
          • Medical Ethics Committee of Children's Hospital of Nanjing Med
          • Numero di telefono: +86 189 5176 2937
          • Email: drsunfei@njmu.edu.cn

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Children aged 2 to 12 years.
  2. Scheduled to undergo elective day surgery under general anesthesia.
  3. ASA (American Society of Anesthesiologists) physical status I to III.

Exclusion Criteria:

  1. Congenital diseases or severe liver or kidney dysfunction.
  2. History of allergic reactions to study drugs.
  3. Neuromuscular diseases, cerebral palsy, epilepsy.
  4. Other psychiatric or neurological disorders.
  5. Body mass index (BMI) ≥ 30 kg/m².
  6. Severe upper respiratory tract infections prior to surgery.
  7. Use of sedatives or analgesics within 48 hours before surgery.
  8. Exposure to major life stressors within 1 month before surgery (e.g., family separation, death of a parent).
  9. Refusal to participate or failure to obtain consent from the child's legal guardian.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intranasal Dexmedetomidine
Participants receive intranasal dexmedetomidine 2.0 micrograms/kg approximately 30 minutes before induction of general anesthesia.
Droga: Dexmedetomidine
Intranasal dexmedetomidine 2.0 micrograms/kg administered once approximately 30 minutes before induction of general anesthesia.
Altri nomi:
  • Dexmedetomidina cloridrato
Sperimentale: Intranasal Esketamine
Participants receive intranasal esketamine 1.0 mg/kg approximately 30 minutes before induction of general anesthesia.
Droga: Esketamine
Intranasal esketamine 1.0 mg/kg administered once approximately 30 minutes before induction of general anesthesia.
Altri nomi:
  • Esketamine Hydrochloride
Comparatore placebo: Normal Saline Control
Participants receive an equal volume of intranasal normal saline approximately 30 minutes before induction of general anesthesia.
Droga: Normal Saline
Intranasal normal saline of equal volume administered once approximately 30 minutes before induction of general anesthesia.
Altri nomi:
  • Cloruro di sodio allo 0,9%.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Negative Postoperative Behavioral Changes on Postoperative Day 7
Lasso di tempo: Postoperative Day 7
Incidence of negative postoperative behavioral changes assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
Postoperative Day 7

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Negative Postoperative Behavioral Changes on Postoperative Day 3
Lasso di tempo: Postoperative Day 3
Incidence of negative postoperative behavioral changes assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
Postoperative Day 3
Incidence of Negative Postoperative Behavioral Changes on Postoperative Day 28
Lasso di tempo: Postoperative Day 28
Incidence of negative postoperative behavioral changes assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
Postoperative Day 28

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Sedation Score 30 Minutes After Study Drug Administration
Lasso di tempo: 30 minutes after study drug administration
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.
30 minutes after study drug administration
Postoperative Pain Score
Lasso di tempo: At the time of emergence in the post-anesthesia care unit
Pain intensity assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. Scores range from 0 to 10, with higher scores indicating worse pain.
At the time of emergence in the post-anesthesia care unit
Emergence Delirium Score
Lasso di tempo: After emergence in the post-anesthesia care unit
Emergence delirium assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Scores range from 0 to 20, with higher scores indicating worse emergence delirium.
After emergence in the post-anesthesia care unit
Intraoperative Electroencephalographic Parameters Before Emergence Description
Lasso di tempo: From induction of anesthesia until before emergence
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.
From induction of anesthesia until before emergence
Incidence of Perioperative Adverse Events
Lasso di tempo: 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)
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.
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)
Emergence Time
Lasso di tempo: In the post-anesthesia care unit on the day of surgery
Time from discontinuation of anesthesia to emergence.
In the post-anesthesia care unit on the day of surgery
Postoperative Time to Discharge
Lasso di tempo: From end of surgery to discharge on the day of surgery
Time from the end of surgery to hospital discharge.
From end of surgery to discharge on the day of surgery
Parental Satisfaction Score Assessed by the Pediatric Anesthesia Parent Satisfaction (PAPS) Questionnaire
Lasso di tempo: On the day of surgery before discharge
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.
On the day of surgery before discharge

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Nanjing Children's Hospital

Collaboratori

Nanjing First Hospital, Nanjing Medical University
Zhongda Hospital
Wuxi Women's & Children's Hospital

Investigatori

  • Investigatore principale: fei sun, Master's, Children's Hospital of Nanjing Medical University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

30 novembre 2027

Completamento dello studio (Stimato)

30 novembre 2027

Date di iscrizione allo studio

Primo inviato

12 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 202512066-2
  • SWYY2025002065 (Altro numero di sovvenzione/finanziamento: ISEFC, China)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

At this time, there are no plans to share individual participant data (IPD) from this study. The decision may be revisited in the future based on data confidentiality, privacy concerns, and any relevant regulatory requirements.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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