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

NCT ID: NCT04258007

Last Updated: 2021-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-27
• Study Completion Date: 2020-11-18

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

Conditions

Cardiac Catheterization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: PLACEBO_COMPARATOR

Reversal Neostigmine

Intervention Type: DRUG

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

Reversal Sugammadex

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

Group Type: ACTIVE_COMPARATOR

Reversal Sugammadex

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Reversal Sugammadex

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

Intervention Type: DRUG

Other Intervention Names

PROSTIGMIN®; BRIDION®

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sherif A Mousa, MD

Role: STUDY_CHAIR

Professor of Anaesthesia and Surgical Intensive Care

Amgad A Zaghloul, MD

Role: STUDY_DIRECTOR

Associate Professor of Anaesthesia and Surgical Intensive Care

Locations

Mansoura University

Al Mansurah, DK, Egypt

Countries

Egypt

Other Identifiers

MS.19.08.759

Identifier Type: -

Identifier Source: org_study_id