NCT04258007

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 1 Day – 2 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cardiac Catheterization

Interventions

Type	Name	Description
DRUG	Reversal Neostigmine	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
DRUG	Reversal Sugammadex	Interventional Arm Patients undergoing cardiac catheterization will receive sugammadex 4 mg/ kg when the T2 is observed on the TOF watch

Timeline

• Start date: 2020-01-27
• Primary completion: 2020-11-10
• Completion: 2020-11-18
• First posted: 2020-02-06
• Last updated: 2021-06-16

Locations

1 site across 1 country: Egypt