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NOT YET RECRUITING
NCT07011134
PHASE3

Timing of Aminophylline and Recovery in Pediatric Ambulatory Surgery

Sponsor: Hany Mohammed El-Hadi Shoukat Mohammed

View on ClinicalTrials.gov

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.

Official title: Effect of Early Versus Late Aminophylline Administration on Recovery Profile in Pediatric Patients Undergoing Ambulatory Surgery Under General Anesthesia; a Randomised Controlled Trial

Key Details

Gender

All

Age Range

4 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-06-15

Completion Date

2025-08-15

Last Updated

2025-06-08

Healthy Volunteers

No

Interventions

DRUG

Group (E): receive aminophylline early intraoperatively,

Group E (n=20): patients received aminophylline at an early intraoperative time immediately after fixation of ETT and confirmation of bilateral adequate lung ventilation (EtSevo\< 1)

DRUG

Group (L) received aminophylline late intraoperatively

Group L (n=20): patients received aminophylline at late intraoperative time immediately after discontinuation of sevoflurane (EtSevo \< 1).

DRUG

Group (C) will receive normal saline post-anesthetic discontinuation.

Group (C) (n=20): patients received normal saline immediately after discontinuation of sevoflurane (EtSevo \< 1).