Timing of Aminophylline and Recovery in Pediatric Ambulatory Surgery

NCT07011134 | Not Yet Recruiting Phase 3

• 1 other identifier: MS-408-2024
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

pediatric; recovery of conciousness; aminophylline; sevoflurane; Ped PADSS; home readiness

Outcome Measures

Primary Outcomes (1)

• Recovery of consciousness (ROC) time

  Recovery of consciousness (ROC) time will be defined as the postoperative time interval in minutes from discontinuation of anesthetics to eye opening in response to verbal or tactile command up to 30 minutes from discontinuation of anesthetics.

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

Secondary Outcomes (6)

• Home readiness discharge time

  started from admission to PACU untill Ped PADSS reached at least 9 up to 2 hours postoperatively

• Total recovery time

  started from discontinuation of sevoflurane anesthesia till Ped-PADSS reached at least 9 up to 2.5 hours after discontinuation of anesthetics

• Level of sedation

  5 minutes after extubation, on admission to the PACU, and when the Pediatric Post Anesthetic Discharge Scoring System (Ped-PADSS) reached 9.

• Incidence of ED

  5 minutes after PACU admission.

• Adverse events

  postoperatively

Other Outcomes (8)

• Demographic data and clinical characteristics

  preoperative assessment

• hemodynamics (1)

  T0=immediately before GA induction,T1=immediately after ETT fixation,T3=15 minutes after ETT fixation,T4=immediately before sevoflurane discontinuation,T5=5 minutes after itsdiscontinuation,T6=5 minutes after extubation,T7=10 minutes after PACU transfer

• Demographic data and clinical characteristics (2)

  preoperative assessment

Study Arms (3)

Group E will receive aminophylline at an early intraoperative time immediately after fixation of E

ACTIVE COMPARATOR

Group E (n=20): patients will receive aminophylline (5 mg/Kg) at an early intraoperative time immediately after fixation of ETT and confirmation of bilateral adequate lung ventilation (EtSevo\< 1).

Drug: Group (E): receive aminophylline early intraoperatively,

Group L will receive aminophylline at late intraoperative time immediately after disco

ACTIVE COMPARATOR

Group L (n=20): patients will receive aminophylline (5 mg/Kg) at late intraoperative time immediately after discontinuation of sevoflurane (EtSevo \< 1)

Drug: Group (L) received aminophylline late intraoperatively

Group (C) will receive normal saline immediately after discontinuation of sevoflurane

PLACEBO COMPARATOR

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

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

Interventions

Group (E): receive aminophylline early intraoperatively, DRUG

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)

Also known as: Early aminophylline group

Group E will receive aminophylline at an early intraoperative time immediately after fixation of E

Group (L) received aminophylline late intraoperatively DRUG

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

Group L will receive aminophylline at late intraoperative time immediately after disco

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

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

Group (C) will receive normal saline immediately after discontinuation of sevoflurane

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hany Mohammed El-Hadi Shoukat Mohammed: lead

Related Publications (3)

• El Tahan MR. Effects of aminophylline on cognitive recovery after sevoflurane anesthesia. J Anesth. 2011 Oct;25(5):648-56. doi: 10.1007/s00540-011-1190-8. Epub 2011 Jul 14.

  PMID: 21755342 BACKGROUND

• Chen Yang, Tingting Wu, Linrui Tang, Xuebing Zhang. A prospective observational study comparing the pediatric post anesthesia discharge scoring system with clinical discharge criteria in pediatric day surgical patients in Western China. Research square 2012.

  BACKGROUND

• Kasim SA, Bahr MH, Abdelkader M, Rashwan DAE. The effect of preoperative aminophylline on the recovery profile after major pelvic-abdominal surgeries: a randomized controlled double-blinded study. BMC Anesthesiol. 2021 Apr 19;21(1):122. doi: 10.1186/s12871-021-01340-7.

  PMID: 33874898 BACKGROUND

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Neven AbdElmalk Gouda, MD

  kasr Alainy Medical School/Cairo University

  STUDY CHAIR

• Menna T'Allah A.Mahmoud Gebril, MSc

  kasr Alainy Medical School/Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hany M.El-Hadi Mohammed, MD

CONTACT

+201003066806; oblfollower_2001@yahoo.com, hany.elhadi@kasralainy.edu.eg

Mohammed M. Kamel Anwar, MD

CONTACT

+201005238534

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: June 8, 2025
• Study Start: June 15, 2025
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-05