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

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

Study Overview

• Status: Completed
• Conditions: Cardiac Catheterization
• Intervention / Treatment: Drug: Reversal Neostigmine; Drug: Reversal 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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansoura, DK, Egypt, 050
      • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 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	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; Other Names: PROSTIGMIN®
ACTIVE_COMPARATOR: Reversal Sugammadex; Patients undergoing cardiac catheterization will receive sugammadex 4 mg/ kg when the T2 is observed 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; Other Names: BRIDION®

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Sherif A Mousa, MD, Professor of Anaesthesia and Surgical Intensive Care; Study Director: Amgad A Zaghloul, MD, Associate Professor of Anaesthesia and Surgical Intensive Care

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 27, 2020
• Primary Completion (ACTUAL): November 10, 2020
• Study Completion (ACTUAL): November 18, 2020

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (ACTUAL): February 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 14, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Parasympathomimetics; Neostigmine
• Other Study ID Numbers: MS.19.08.759

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Following publication
• IPD Sharing Time Frame: forever
• IPD Sharing Access Criteria: ahmed.refaat.rezk@gmail.com
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No