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

NCT07766629 | Not Yet Recruiting

• 1 other identifier: Propofol TIVA Recovery by Age
• Study Type: observational
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Anesthesia Recovery; Pediatric Anesthesia; Total Intravenous Anesthesia

Keywords

Propofol; TIVA; Emergence Delirium; Postoperative Nausea and Vomiting; PAED Scale

Outcome Measures

Primary Outcomes (1)

• Time to Achieve Fast-Track Phase II Recovery Readiness

  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.

  2 hours post-surgery

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of pediatric patients aged 3 to 12 years with an American Society of Anesthesiologists (ASA) physical status of I or II, scheduled for elective surgical procedures at Assiut University Hospitals. Eligible participants are those anticipated to have a surgical duration between 30 and 120 minutes and who receive propofol-based total intravenous anesthesia (TIVA) as their primary anesthetic technique. Patients are excluded from the population if they present with neurological disorders, developmental delay, hepatic or renal impairment, obesity (greater than the 95th percentile), or if they are taking concomitant sedative medications.

You may qualify if:

• Age 3-12 years
• ASA I-II
• Elective surgery under general anaesthesia
• Surgical duration 30-120 minutes
• Propofol TIVA as the primary anesthetic technique

You may not qualify if:

• Neurological disorders
• Developmental delay
• Hepatic or renal impairment
• Obesity (\>95th percentile)
• Concomitant sedative medications

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Emergence Delirium; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Nausea; Signs and Symptoms, Digestive; Vomiting

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 14, 2026

Record last verified: 2026-08