Sugammadex Versus Neostigmine in Pediatric Less Than Two Years Undergoing Cardiac Catheterization

Study Overview
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Brief Summary
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This study hypothesizes that Sugammadex may has more appropriate recovery profile than neostigmine in pediatric cardiac patients undergoing cardiac catheterization. In pediatric cardiac patients, clear and rapid recovery (fast-tracking) is required to maintain hemodynamic within the normal physiological values which may be saved by sugammadex

Detailed Description
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There are numerous advantages of early tracheal extubation otherwise known as fast-tracking following anesthesia for congenital heart disease (CHD) Early tracheal extubation not only eliminates the potential morbidity related to an endotracheal tube and mechanical ventilation such as atelectasis, accumulation of secretions, nosocomial infections, and the potential for airway trauma, it also limits the need for sedation and the antecedent adverse effects including respiratory and hemodynamic depression, tolerance, withdrawal, and delirium. Most importantly, the shift from positive pressure to spontaneous ventilation augments cardiovascular function and improves preload. Reversal of neuromuscular blockade is a fundamental aspect of emergence from general anesthesia. Historically, the only option to actively reverse blockade will be to administer anticholinesterase inhibitors, which are unable to reverse deep neuromuscular blockade. They are also associated with a variety of cholinergic side effects, including bradycardia, nausea, and increased secretions, which require concomitant administration of an anticholinergic agent, with its own adverse effects. Sugammadex is a newer, selective relaxant binding agent

Official Title
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Recovery Profile of Sugammadex Versus Neostigmine in Pediatric Patients Undergoing Cardiac Catheterization: a Randomized Double-blind Study

Conditions
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Cardiac Catheterization

Intervention / Treatment
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* Drug: Reversal Neostigmine
* Drug: Reversal Sugammadex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists physical status (ASA) I-III Exclusion Criteria: Legal guardian refusal. Any patients with known drug hypersensitivity. Kidney failure. Liver failure. Diseases affecting the neuromuscular junction. A history of malignant hyperthermia

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Reversal Neostigmine<br>Patients undergoing cardiac catheterization will receive a combination of 0.02 mg/ kg atropine and 0.04 mg/ kg neostigmine following observing the second response on stimulating the ulnar nerve on the TOF watch | Drug: Reversal Neostigmine<br>* Patients will receive 0.02 mg/ kg atropine and 0.04 mg/ kg neostigmine following observing the second response on stimulating the ulnar nerve on the TOF watch<br>* Other names: PROSTIGMIN®;|
| Active Comparator: Reversal Sugammadex<br>Patients undergoing cardiac catheterization will receive sugammadex 4 mg/ kg when the T2 is observed on the TOF watch | Drug: Reversal Sugammadex<br>* Interventional Arm Patients undergoing cardiac catheterization will receive sugammadex 4 mg/ kg when the T2 is observed on the TOF watch<br>* Other names: BRIDION®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reversal efficacy | Mean time in minutes from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9 | 90 minutes after endotracheal extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate |  | assessed basal, after induction, every 15 min during operation ,.just before reversal, and at 1,2,5,7,10,15 minutes after reversal | 
| Mean arterial blood pressure |  | basal, after induction, every 15 min during operation ,.just before reversal, and at 1,2,5,7,10,15 minutes after reversal | 
| Diastolic arterial blood pressure |  | basal, after induction, every 15 min during operation ,.just before reversal, and at 1,2,5,7,10,15 minutes after reversal | 
| Peripheral oxygen saturation |  | basal, after induction, every 15 min during operation , just before reversal, at 1,2,5,7,10,15 minutes after reversal | 
| vomiting | patients monitored for incidence and rate of vomiting by clinical observation in PACU for 24 hours after sugammadex or neostigmine administration . | for 24 hour after sugammadex or neostigmine administration | 
| Anaphylaxis | patients monitored after sugammadex or neostigmine administration for 24 hours postoperative for The National Institute of Allergy and Infectious Diseases (NIAID) and the Food Allergy and Anaphylaxis Network (FAAN) proposed clinical criteria for diagnosing anaphylaxis . Depending on the severity of the reaction, four grades of immediate clinical manifestations are described: Grade 1, Cutaneous signs only; Grade 2, Measurable but not life-threatening symptoms and cutaneous signs,hypotension, tachycardia, and respiratory disturbances, such as cough and difficulty in lung inflation; Grade 3, Life-threatening symptoms: collapse, tachycardia or bradycardia, arrhythmias, bronchospasm; Grade 4, Cardiac and/or respiratory arrest | for 24 hour after sugammadex or neostigmine administration | 
| blood glucose | blood glucose in (mg/dL) measured using a GLUCOMETER with strip | preoperative, 15 minutes before reversal and 30 minutes after reversal | 
| prothrombin time | PT in seconds measured Just before reversal and 60 min after reversal administration. | intraoperative and for 60 minutes after sugammadex or neostigmine administration | 
| activated prothromboplastin time | APTT in seconds measured Just before reversal and 60 min after reversal administration. | intraoperative and for 60 minutes after sugammadex or neostigmine administration |