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

29 april 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

342

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

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

Studieorter

  • 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-post: drsunfei@njmu.edu.cn

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Intranasal Dexmedetomidine
Participants receive intranasal dexmedetomidine 2.0 micrograms/kg approximately 30 minutes before induction of general anesthesia.
Läkemedel: Dexmedetomidine
Intranasal dexmedetomidine 2.0 micrograms/kg administered once approximately 30 minutes before induction of general anesthesia.
Andra namn:
  • Dexmedetomidinhydroklorid
Experimentell: Intranasal Esketamine
Participants receive intranasal esketamine 1.0 mg/kg approximately 30 minutes before induction of general anesthesia.
Läkemedel: Esketamine
Intranasal esketamine 1.0 mg/kg administered once approximately 30 minutes before induction of general anesthesia.
Andra namn:
  • Esketamine Hydrochloride
Placebo-jämförare: Normal Saline Control
Participants receive an equal volume of intranasal normal saline approximately 30 minutes before induction of general anesthesia.
Läkemedel: Normal Saline
Intranasal normal saline of equal volume administered once approximately 30 minutes before induction of general anesthesia.
Andra namn:
  • 0,9% natriumklorid

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Sedation Score 30 Minutes After Study Drug Administration
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Nanjing Children's Hospital

Samarbetspartners

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

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juni 2026

Primärt slutförande (Beräknad)

30 november 2027

Avslutad studie (Beräknad)

30 november 2027

Studieregistreringsdatum

Först inskickad

12 april 2026

Först inskickad som uppfyllde QC-kriterierna

29 april 2026

Första postat (Faktisk)

6 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 april 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 202512066-2
  • SWYY2025002065 (Annat bidrag/finansieringsnummer: ISEFC, China)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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