Clinical trial NCT04258007: Sugammadex Versus Neostigmine in Pediatric Less Than Two Years Undergoing Cardiac Catheterization
Official title: Recovery Profile of Sugammadex Versus Neostigmine in Pediatric Patients Undergoing Cardiac Catheterization: a Randomized Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Catheterization
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Reversal efficacy
timeFrame: 90 minutes after endotracheal extubation
Secondary outcomes:
measure: Heart rate
timeFrame: assessed basal, after induction, every 15 min during operation ,.just before reversal, and at 1,2,5,7,10,15 minutes after reversal
measure: Mean arterial blood pressure
timeFrame: basal, after induction, every 15 min during operation ,.just before reversal, and at 1,2,5,7,10,15 minutes after reversal
measure: Diastolic arterial blood pressure
timeFrame: basal, after induction, every 15 min during operation ,.just before reversal, and at 1,2,5,7,10,15 minutes after reversal
measure: Peripheral oxygen saturation
timeFrame: basal, after induction, every 15 min during operation , just before reversal, at 1,2,5,7,10,15 minutes after reversal
measure: vomiting
timeFrame: for 24 hour after sugammadex or neostigmine administration
measure: Anaphylaxis
timeFrame: for 24 hour after sugammadex or neostigmine administration
measure: blood glucose
timeFrame: preoperative, 15 minutes before reversal and 30 minutes after reversal
measure: prothrombin time
timeFrame: intraoperative and for 60 minutes after sugammadex or neostigmine administration
measure: activated prothromboplastin time
timeFrame: intraoperative and for 60 minutes after sugammadex or neostigmine administration
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: DK
Study officials:
affiliation: Professor of Anaesthesia and Surgical Intensive Care
name: Sherif A Mousa, MD
role: STUDY_CHAIR
affiliation: Associate Professor of Anaesthesia and Surgical Intensive Care
name: Amgad A Zaghloul, MD
role: STUDY_DIRECTOR
References: