- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07766629
Recovery Trajectories After Propofol-Based Intravenous Anesthesia in Toddlers and Older Children
Age-Stratified Recovery Trajectories Following Propofol-Based Total Intravenous Anesthesia: A Comparative Study Between Toddlers (3-6 Years) and Older Children (6-12 Years)
This observational study aims to compare how quickly and smoothly younger children (ages 3 to 6 years) recover from general anesthesia compared to older children (ages 6 to 12 years).
While inhalational anesthesia (breathing in anesthetic gases) has traditionally been the standard for pediatric surgeries, total intravenous anesthesia (TIVA) using a short-acting medication called propofol is increasingly being used. Propofol TIVA offers several benefits, including reduced postoperative nausea and vomiting, less airway irritation, a smoother waking process, and an earlier readiness to go home. However, because children's bodies and metabolisms change rapidly as they grow, the way propofol is processed by and clears from the body varies significantly by age.
Currently, there is limited evidence detailing exactly how these age-related differences affect recovery times. To investigate this, researchers will monitor 64 children undergoing elective surgeries (lasting between 30 and 120 minutes) who receive propofol TIVA as their primary anesthetic.
After the procedure, the study will measure the exact time it takes for participants in both age groups to meet specific, standardized safe-discharge criteria (known as Phase II recovery readiness). Researchers will also track several other important recovery factors, including the time it takes for children to open their eyes, pain levels, the occurrence of emergence delirium (agitation or confusion upon waking), and any breathing-related complications. By comparing the recovery trajectories of toddlers and older children, this research seeks to improve postoperative care planning and provide clearer expectations for pediatric intravenous anesthesia.
Studienübersicht
Status
Studientyp
Einschreibung (Geschätzt)
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Age 3-12 years
- ASA I-II
- Elective surgery under general anaesthesia
- Surgical duration 30-120 minutes
- Propofol TIVA as the primary anesthetic technique
Exclusion Criteria:
- Neurological disorders
- Developmental delay
- Hepatic or renal impairment
- Obesity (>95th percentile)
- Concomitant sedative medications
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Toddlers (3-6 years)
Pediatric patients aged 3 to 6 years undergoing elective surgery under general anesthesia.
This cohort receives a standardized propofol-based total intravenous anesthesia (TIVA) protocol, which includes induction with propofol (2-3 mg/kg IV) and maintenance via continuous infusion utilizing Kataria model predictions.
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Older Children (6-12 years)
Pediatric patients aged 6 to 12 years undergoing elective surgery under general anesthesia.
This cohort receives a standardized propofol-based total intravenous anesthesia (TIVA) protocol, which includes induction with propofol (2-3 mg/kg IV) and maintenance via continuous infusion utilizing Kataria model predictions.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Time to Achieve Fast-Track Phase II Recovery Readiness
Zeitfenster: 2 hours post-surgery
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The time elapsed in minutes from the end of surgery (defined as the placement of the last stitch) until the patient achieves Phase II recovery readiness.
Readiness is determined using the White Fast-Track Score, which requires patients to achieve a total score of 12 or greater with no individual component scoring less than 1.
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2 hours post-surgery
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Mitarbeiter und Ermittler
Sponsor
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
- Neurologische Manifestationen
- Erkrankungen des Nervensystems
- Psychische Störungen
- Postoperative Komplikationen
- Pathologische Prozesse
- Anzeichen und Symptome, Verdauungstrakt
- Verwirrtheit
- Neurobehaviorale Manifestationen
- Neurokognitive Störungen
- Delirium
- Erbrechen
- Brechreiz
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Entstehung Delirium
- Postoperative Übelkeit und Erbrechen
Andere Studien-ID-Nummern
- Propofol TIVA Recovery by Age
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