Effect of Early Versus Late Aminophylline Administration on Recovery Profile in Pediatric Patients Undergoing Ambulatory Surgery Under General Anesthesia; a Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Recovery of consciousness (ROC) time
研究概览
简要总结
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.
详细描述
An online randomization program (http://www. Randomizer.org) will be used to generate a random list and each patient's code will be kept in an opaque sealed envelope. Patients will be randomly allocated with 1:1:1 allocation ratio into three equal groups in a parallel manner:
- Group E (n=20): patients will receive aminophylline at an early intraoperative time immediately after fixation of ETT and confirmation of bilateral adequate lung ventilation (EtSevo< 1).
- Group L (n=20): patients will receive aminophylline at late intraoperative time immediately after discontinuation of sevoflurane (EtSevo < 1).
- Group (C) (n=20): patients will receive normal saline immediately after discontinuation of sevoflurane (EtSevo < 1). Patients and outcome assessors will be blinded to the group of the patients. An independant anesthetist who is not involved in the study will prepare the interventional medications.
Preoxygenation with 100% oxygen will be done for 3 min. An intravenous cannula will be inserted after inhalational induction of sevoflurane at 8%. Then, General anesthesia will be induced by propofol (2.0 mg/kg), fentanyl (1.0 mcg/kg) and atracurium (0.5 mg/kg) endotracheal intubation will be performed after full relaxation.
Anesthesia will be maintained with sevoflurane (2.0%-3.0%) to keep EtSevo 2.0 % in an O2/air mixture, and top up doses of atracurium every 30 min. Fresh gas flow will be set at 3 L/min all through the intraoperative period. Minute ventilation will be adjusted to maintain normocapnia (end tidal carbon dioxide; et CO2, between 32- and 34-mm Hg application of 5.0 mmHg of PEEP).
Two syringes will be prepared by an independent anesthesiologist for each patient. One syringe contains 5.0 mg/kg aminophylline while the other syringe contains a similar volume of normal saline. Then according to the allocated group, the independent anesthesiologist injected the syringe in an appropriate time and rate (over 10 min). All patients will receive Lactated Ringer's solution infused at a rate of 2.0-3.0 mL/kg/h and dexamethasone at 0.15 mg/Kg as antiemetic. Normothermia will be maintained by warming the IV fluids and using Bair Hugger warming system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group L will receive aminophylline at late intraoperative time immediately after disco
Group L (n=20): patients will receive aminophylline (5 mg/Kg) at late intraoperative time immediately after discontinuation of sevoflurane (EtSevo < 1)
干预措施: Group (L) received aminophylline late intraoperatively (Drug)
Group (C) will receive normal saline immediately after discontinuation of sevoflurane
Group (C) (n=20): patients will receive normal saline immediately after discontinuation of sevoflurane (EtSevo < 1).
干预措施: Group (C) will receive normal saline post-anesthetic discontinuation. (Drug)
Group E will receive aminophylline at an early intraoperative time immediately after fixation of E
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).
干预措施: Group (E): receive aminophylline early intraoperatively, (Drug)
结局指标
主要结局
Recovery of consciousness (ROC) time
时间窗: from discontinuation of anesthetics to eye opening in response to verbal or tactile command up to 30 minutes from discontinuation of anesthetics
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.
次要结局
- 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)
- Home readiness discharge time(started from admission to PACU untill Ped PADSS reached at least 9 up to 2 hours postoperatively)
- 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)
- Pediatric Post-Anesthetic Discharge Scoring System (Ped-PADSS)(immediately after PACU admission and every 5 minutes until it reached at least 9 points.)
研究者
Hany Mohammed El-Hadi Shoukat Mohammed
Assistant Professor
Cairo University