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

NCT04258007 | Completed DMC

• 1 other identifier: MS.19.08.759
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiac Catheterization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

  for 24 hour after sugammadex or neostigmine administration

Study Arms (2)

Reversal Neostigmine

PLACEBO COMPARATOR

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

Reversal Sugammadex

ACTIVE COMPARATOR

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

Drug: Reversal Sugammadex

Interventions

Reversal Neostigmine 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

Also known as: PROSTIGMIN®

Reversal Neostigmine

Reversal Sugammadex DRUG

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

Also known as: BRIDION®

Reversal Sugammadex

Eligibility Criteria

• Age: 1 Day - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• American Society of Anesthesiologists physical status (ASA) I-III

You may not qualify if:

• Legal guardian refusal.
• Any patients with known drug hypersensitivity.
• Kidney failure.
• Liver failure.
• Diseases affecting the neuromuscular junction.
• A history of malignant hyperthermia

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Interventions

Neostigmine; Sugammadex

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Sherif A Mousa, MD

  Professor of Anaesthesia and Surgical Intensive Care

  STUDY CHAIR

• Amgad A Zaghloul, MD

  Associate Professor of Anaesthesia and Surgical Intensive Care

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double blind (Participant, Care Provider)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: February 6, 2020
• Study Start: January 27, 2020
• Primary Completion: November 10, 2020
• Study Completion: November 18, 2020
• Last Updated: June 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: forever
• Access Criteria: ahmed.refaat.rezk@gmail.com

Locations

EG (1)