Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study (CLONIDEX)
Comparison of Intravenously Administered Dexmedetomidine Versus Clonidine Versus No Alpha-2 Agonist on Emergence Delirium, PACU Length of Stay, and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: A Prospective Observational Study
Emergence delirium (ED) is a frequent complication in children undergoing general anesthesia, particularly following ENT procedures such as adenotonsillectomy. Alpha-2 adrenergic agonists, such as clonidine and dexmedetomidine, are commonly used in pediatric anesthesia for their sedative, analgesic, and ED-reducing properties.The purpose of this prospective observational study (CLONIDEX) is to evaluate and compare the occurrence of emergence delirium, Post-Anesthesia Care Unit (PACU) length of stay, and overall time to hospital discharge in pediatric patients undergoing (adeno)tonsillectomy with or without placement of myringotomy tubes who receive intravenous dexmedetomidine, intravenous clonidine, or no alpha-2 agonist as part of their standard anesthetic care.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Background:
Emergence delirium (ED) in pediatric patients leads to increased post-anesthesia care unit (PACU) complications, distress for parents and staff, and potential physical injury. While both clonidine and dexmedetomidine are widely utilized alpha-2 agonists in pediatric practice, real-world prospective comparative data regarding their relative efficacy on ED incidence and recovery timelines remain limited.
Study Design and Methodology This is a single-center, prospective observational cohort study conducted at UZ Brussel. Because this is an observational study evaluating standard-of-care practices, the administration and choice of alpha-2-agonist (IV dexmedetomidine, IV clonidine, or no alpha-2-agonist) are left entirely to the discretion of the attending pediatric anesthesiologist.
Data Collection and Outcomes:
Pediatric patients undergoing elective (adeno)tonsillectomy with or without placement of myringotomy tubes will be observed. Key demographic data, anesthetic techniques, and intraoperative co-analgesics will be recorded. Upon arrival in the PACU, emergence delirium will be systematically assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale at set time intervals (arrival, 15, 30, 45, and 60 minutes). Secondary endpoints include PACU length of stay (measured against standardized discharge readiness criteria), total time to hospital discharge, requirement for rescue medication, and incidence of perioperative adverse events (such as postoperative nausea and vomiting, desaturation, or laryngospasm).
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Hélène De Cuyper, MD
- Telefonnummer: +3224749765
- E-Mail: helene.decuyper@uzbrussel.be
Studieren Sie die Kontaktsicherung
- Name: Liza De Dobbeleer, Study Nurse
- E-Mail: liza.dedobbeleer@uzbrussel.be
Studienorte
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Brussels Capital
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Jette, Brussels Capital, Belgien, 1090
- Universitair Ziekenhuis Brussel
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Kontakt:
- Hélène De Cuyper, MD
- Telefonnummer: +3224749765
- E-Mail: helene.decuyper@uzbrussel.be
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
The study population consists of pediatric patients aged 2 to 12 years (ASA I-II) scheduled for elective ambulatory (adeno)tonsillectomy with or without placement of myringotomy tubes under general anesthesia at UZ Brussel. Participants are selected from the daily operating room list in the day-surgery unit.
Beschreibung
Inclusion Criteria:
- Children aged 2 to 12 years old.
- Scheduled for elective (adeno)tonsillectomy or tonsillectomy (with or without concurrent myringotomy/tympanostomy tube insertion).
- American Society of Anesthesiologists (ASA) physical status I or II.
- Surgery performed in an ambulatory / day-surgery setting under general anesthesia.
- Written informed consent provided by parents or legal guardians.
Exclusion Criteria:
- Known hypersensitivity or allergy to clonidine, dexmedetomidine, or other alpha-2 adrenergic agonists.
- Pre-existing severe cardiac conduction abnormalities, severe bradycardia, or hemodynamic instability.
- Severe neurodevelopmental impairment, severe cognitive impairment, or active central nervous system disorders that preclude reliable assessment using the PAED scale.
- Emergency tonsillectomy or active tonsillar hemorrhage.
- Patients requiring planned postoperative intensive care unit (PICU) admission or extended inpatient monitoring.
- Patient or parent/guardian refusal to participate.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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Dexmedetomidine Group
Pediatric patients undergoing elective (adeno)tonsillectomy with or without placement of myringotomy tubes who receive intraoperative intravenous dexmedetomidine as part of standard anesthetic care, at the discretion of the attending anesthesiologist. |
Standard of care intraoperative intravenous administration of dexmedetomidine. Dose, timing, and administration are determined solely by the attending anesthesiologist. |
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Clonidine Group
Pediatric patients undergoing elective (adeno)tonsillectomy with or without placement of myringotomy tubes who receive intraoperative intravenous clonidine as part of standard anesthetic care, at the discretion of the attending anesthesiologist. |
Standard of care intraoperative intravenous administration of clonidine. Dose, timing, and administration are determined solely by the attending anesthesiologist. |
|
Control Group (No Alpha-2 Agonist)
Pediatric patients undergoing elective (adeno)tonsillectomy with or without placement of myringotomy tubes who do not receive any intraoperative alpha-2 adrenergic agonist (dexmedetomidine or clonidine) as part of standard anesthetic care. |
Standard anesthetic care during pediatric (adeno)tonsillectomy without administration of intraoperative alpha-2 adrenergic agonists. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Incidence and Severity of Emergence Delirium (ED)
Zeitfenster: Assessed at PACU arrival (T0), and at 15 (T15), 30 (T30), 45 (T45), and 60 (T60) minutes post-operatively until PACU discharge.
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Emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The PAED scale consists of 5 items, with total scores ranging from 0 to 20, where higher scores indicate greater severity of delirium. A PAED score >= 10 (or >= 12) is defined as the presence of emergence delirium. |
Assessed at PACU arrival (T0), and at 15 (T15), 30 (T30), 45 (T45), and 60 (T60) minutes post-operatively until PACU discharge.
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Post-Anesthesia Care Unit (PACU) Length of Stay
Zeitfenster: From arrival at PACU until discharge readiness, assessed up to 2 hours post-operatively.
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Time duration (in minutes) from arrival at the PACU until meeting formal criteria for discharge readiness (e.g., modified Aldrete or PADSS score). |
From arrival at PACU until discharge readiness, assessed up to 2 hours post-operatively.
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Total Time to Hospital Discharge
Zeitfenster: From end of surgery until hospital discharge on Day 1 (up to 24 hours).
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Time duration (in hours) from the end of anesthesia/surgery until actual discharge from the day-surgery clinic. |
From end of surgery until hospital discharge on Day 1 (up to 24 hours).
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Incidence of Rescue Medication Administration
Zeitfenster: During the PACU stay, up to 2 hours post-operatively.
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Proportion of patients requiring rescue medication in the PACU for severe emergence delirium or acute postoperative pain (e.g., propofol, opioids, or additional alpha-2 agonists). |
During the PACU stay, up to 2 hours post-operatively.
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Incidence of Perioperative Adverse Events
Zeitfenster: From anesthesia induction until discharge from the day-surgery clinic (up to 24 hours).
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Occurrence of airway or recovery complications including laryngospasm, oxygen desaturation (<92%), severe postoperative nausea and vomiting (PONV), or excessive sedation. |
From anesthesia induction until discharge from the day-surgery clinic (up to 24 hours).
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Hélène De Cuyper, MD, Department of Anesthesiology & Perioperative Medicine
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Schmerzen
- Neurologische Manifestationen
- Erkrankungen des Nervensystems
- Psychische Störungen
- Postoperative Komplikationen
- Pathologische Prozesse
- Verwirrtheit
- Neurobehaviorale Manifestationen
- Neurokognitive Störungen
- Delirium
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Entstehung Delirium
- Schmerzen, postoperativ
Andere Studien-ID-Nummern
- CLONIDEX
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Patient Privacy & GDPR Compliance:
The study involves a vulnerable pediatric population. Full individual participant data sets, even if pseudonymized, carry a risk of re-identification when combined with detailed clinical and surgical variables, which violates strict European General Data Protection Regulation (GDPR) standards and institutional patient privacy policies.
Absence of Informed Consent for Broad Public Data Sharing:
The informed consent process and ethics committee approval approved for this study specifically cover data collection and analysis by the designated investigation team at UZ Brussel. Participants' legal guardians did not consent to open-access public repository sharing or secondary use of their children's raw individual data by external third parties.
Institutional & Regulatory Restrictions:
In accordance with hospital policy and national regulatory frameworks governing single-center observational clinical research, raw patient-level data remain restricted.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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