CompletedPhase 3

Timing of Aminophylline and Recovery in Pediatric Ambulatory Surgery

Egypt60 participantsStarted 2025-06-15

Plain-language summary

Beyond its established use as a bronchodilator and therapy for apnea of prematurity, aminophylline has demonstrated utility in reversing the effects of anesthetics, enhancing recovery by accelerating respiratory and cognitive functions. Variations in dosage (1-6 mg/kg) have been explored, but questions persist regarding optimal timing and dosing for pediatric surgical populations to achieve maximal efficacy with minimal adverse effects. This randomized controlled study aims to evaluate the effect of early versus late aminophylline administration on recovery profiles in pediatric patients undergoing ambulatory surgery under sevoflurane anesthesia. Sixty children aged 4-12 years will be randomly allocated into three groups: Group (E) will receive aminophylline early intraoperatively, Group (L) will receive aminophylline late intraoperatively, and Group (C) will receive normal saline post-anesthetic discontinuation.

Who can participate

Age range

4 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age from 4 to 12 years. * Both sexes. * American society of Anesthesiologist (ASA) physical status I-II. * Scheduled for pediatric ambulatory elective surgical procedures lasting ≤ three hours duration. Exclusion Criteria: * Parents refusal to participate. * Conditions and diseases interfering with ambulatory day case surgery e.g., significant respiratory diseases, morbid obesity, obstructive sleep apnea, sickle cell anemia, prematurity, D.M, and family history of malignant hyperthermia. * Laparoscopic, endoscopic or abdominal surgeries. * History of cardiac arrhythmia or palpitation. * Patients with congenital heart, significant cardiovascular, respiratory diseases, renal impairment, hepatic dysfunction, hypo/hyperthyroidism or active peptic ulcer disease. * Patients with neurological, psychiatric diseases, cognitive dysfunction, epilepsy or history of convulsions. * Current treatment with xanthines or patient received aminophylline in the previous 24 hr. Hypersensitivity to aminophylline or other methylxanthines. * Patients who need alteration in the sevoflurane concentration due to either hypo/hypertension were excluded from the study and replaced.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recovery of consciousness (ROC) time

Timeframe: from discontinuation of anesthetics to eye opening in response to verbal or tactile command up to 30 minutes from discontinuation of anesthetics

Trial details

NCT IDNCT07011134

SponsorHany Mohammed El-Hadi Shoukat Mohammed

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-15

View on ClinicalTrials.gov More Postoperative Recovery trials