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

Mansoura University

Status: Completed

Conditions: Cardiac Catheterization

Treatments: Drug: Reversal Sugammadex; Drug: Reversal Neostigmine

Study type: Interventional

Funder types: Other

Identifiers

NCT04258007

MS.19.08.759

Details and patient eligibility

About

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

Full 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

Enrollment: 50 patients

Sex: All

Ages: 1 day to 2 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Reversal Neostigmine

Placebo Comparator group

Description:

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

Treatment:

Drug: Reversal Neostigmine

Reversal Sugammadex

Active Comparator group

Description:

Patients undergoing cardiac catheterization will receive sugammadex 4 mg/ kg when the T2 is observed on the TOF watch

Treatment:

Drug: Reversal Sugammadex