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Timing of Aminophylline and Recovery in Pediatric Ambulatory Surgery

NCT07011134 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-06-08

No results posted yet for this study

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.

Conditions

  • Postoperative Recovery
  • Pediatric Anesthesia
  • Ambulatory Surgery

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).

Sponsors & Collaborators

  • Hany Mohammed El-Hadi Shoukat Mohammed

    lead OTHER

Principal Investigators

  • Neven AbdElmalk Gouda, MD · kasr Alainy Medical School/Cairo University

  • Menna T'Allah A.Mahmoud Gebril, MSc · kasr Alainy Medical School/Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-15
Primary Completion
2025-08-15
Completion
2025-08-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07011134 on ClinicalTrials.gov