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

29. april 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

342

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Fei Sun, Master's degree
  • Telefonnummer: +86 181 0061 9994
  • E-mail: drsunfei89@163.com

Studiesteder

  • Kina
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210008
        • Children's Hospital of Nanjing Medical University
        • Kontakt:
          • Medical Ethics Committee of Children's Hospital of Nanjing Med
          • Telefonnummer: +86 189 5176 2937
          • E-mail: drsunfei@njmu.edu.cn

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intranasal Dexmedetomidine
Participants receive intranasal dexmedetomidine 2.0 micrograms/kg approximately 30 minutes before induction of general anesthesia.
Medicin: Dexmedetomidine
Intranasal dexmedetomidine 2.0 micrograms/kg administered once approximately 30 minutes before induction of general anesthesia.
Andre navne:
  • Dexmedetomidinhydrochlorid
Eksperimentel: Intranasal Esketamine
Participants receive intranasal esketamine 1.0 mg/kg approximately 30 minutes before induction of general anesthesia.
Medicin: Esketamine
Intranasal esketamine 1.0 mg/kg administered once approximately 30 minutes before induction of general anesthesia.
Andre navne:
  • Esketamine Hydrochloride
Placebo komparator: Normal Saline Control
Participants receive an equal volume of intranasal normal saline approximately 30 minutes before induction of general anesthesia.
Medicin: Normal Saline
Intranasal normal saline of equal volume administered once approximately 30 minutes before induction of general anesthesia.
Andre navne:
  • 0,9% natriumchlorid

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Negative Postoperative Behavioral Changes on Postoperative Day 7
Tidsramme: Postoperative Day 7
Incidence of negative postoperative behavioral changes assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
Postoperative Day 7

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Negative Postoperative Behavioral Changes on Postoperative Day 3
Tidsramme: 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
Tidsramme: Postoperative Day 28
Incidence of negative postoperative behavioral changes assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
Postoperative Day 28

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sedation Score 30 Minutes After Study Drug Administration
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nanjing Children's Hospital

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: fei sun, Master's, Children's Hospital of Nanjing Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

30. november 2027

Studieafslutning (Anslået)

30. november 2027

Datoer for studieregistrering

Først indsendt

12. april 2026

Først indsendt, der opfyldte QC-kriterier

29. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 202512066-2
  • SWYY2025002065 (Andet bevillings-/finansieringsnummer: ISEFC, China)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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