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

Not Applicable

Completed

• Conditions: Cardiac Catheterization
• Interventions: Drug: Reversal Sugammadex; Drug: Reversal Neostigmine

• Registration Number: NCT04258007
• Lead Sponsor: Mansoura University

Brief Summary

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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-01-27
• Study First Submitted: 2020-01-28
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-06
• Primary Completion: 2020-11-10
• Study Completion: 2020-11-18
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-14
• Last Update Posted: 2021-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• American Society of Anesthesiologists physical status (ASA) I-III

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reversal Sugammadex	Reversal Sugammadex	Patients undergoing cardiac catheterization will receive sugammadex 4 mg/ kg when the T2 is observed on the TOF watch
Reversal Neostigmine	Reversal Neostigmine	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

Primary Outcome Measures

Name	Time	Method
Reversal efficacy	90 minutes after endotracheal extubation	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

Secondary Outcome Measures

Name	Time	Method
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
vomiting	for 24 hour after sugammadex or neostigmine administration	patients monitored for incidence and rate of vomiting by clinical observation in PACU for 24 hours after sugammadex or neostigmine administration .
Peripheral oxygen saturation	basal, after induction, every 15 min during operation , just before reversal, at 1,2,5,7,10,15 minutes after reversal
Anaphylaxis	for 24 hour after sugammadex or neostigmine administration	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
blood glucose	preoperative, 15 minutes before reversal and 30 minutes after reversal	blood glucose in (mg/dL) measured using a GLUCOMETER with strip
prothrombin time	intraoperative and for 60 minutes after sugammadex or neostigmine administration	PT in seconds measured Just before reversal and 60 min after reversal administration.
activated prothromboplastin time	intraoperative and for 60 minutes after sugammadex or neostigmine administration	APTT in seconds measured Just before reversal and 60 min after reversal administration.

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, DK, Egypt