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Not Yet Recruiting NCT07766629

Recovery Trajectories After Propofol-Based Intravenous Anesthesia in Toddlers and Older Children

Conditions: Anesthesia Recovery, Pediatric Anesthesia, Total Intravenous Anesthesia

Sex: All
Ages: 3 Years – 12 Years
Enrollment: 64
Sponsor: Assiut University

Summary

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.

Eligibility Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07766629). StuddyBuddy aggregates publicly available trial information.