Anesthesia RecoveryNCT07766629
Recovery Trajectories After Propofol-Based Intravenous Anesthesia in Toddlers and Older Children
An observational study of Anesthesia Recovery and Pediatric Anesthesia, run by Assiut University.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Anesthesia Recovery, Pediatric Anesthesia, Total Intravenous Anesthesia
- Type of treatment
- Injection or infusion
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- Child
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.
Who may be able to join
- Age 3-12 years
- ASA I-II
- Elective surgery under general anaesthesia
- Surgical duration 30-120 minutes
- Propofol TIVA as the primary anesthetic technique
Who cannot join
- Neurological disorders
- Developmental delay
- Hepatic or renal impairment
- Obesity (>95th percentile)
- Concomitant sedative medications
About this study
Official title: 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.
Read more
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.
- Keywords
- Propofol, TIVA, Emergence Delirium, Postoperative Nausea and Vomiting, PAED Scale
- Medical subject headings
- Emergence Delirium, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia RecoveryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Ashraf Salah Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766629
- Sponsor's protocol ID
- Propofol TIVA Recovery by Age
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-Stratified Recovery Trajectories Following Propofol-Based Total Intravenous Anesthesia: A Comparative Study Between Toddlers (3-6 Years) and Older Children (6-12 Years)
- ClinicalTrials.gov ID
- NCT07766629
- Acronym / sponsor ID
- Propofol TIVA Recovery by Age
- Keywords
- Propofol, TIVA, Emergence Delirium, Postoperative Nausea and Vomiting, PAED Scale
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- Age 3-12 years
- ASA I-II
- Elective surgery under general anaesthesia
- Surgical duration 30-120 minutes
- Propofol TIVA as the primary anesthetic technique
Key exclusion criteria (5 listed)
- Neurological disorders
- Developmental delay
- Hepatic or renal impairment
- Obesity (>95th percentile)
- Concomitant sedative medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to Achieve Fast-Track Phase II Recovery Readiness
Time frame: 2 hours post-surgery
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia Recovery and Pediatric Anesthesia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Achieve Fast-Track Phase II Recovery Readiness (time frame: 2 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.