Different Reversal Agents in Pediatric Day-case Cancer Surgery

NCT ID: NCT03996655

Last Updated: 2019-06-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-30
• Study Completion Date: 2019-10-31

Brief Summary

The aim of this study was to compare the efficacy of sugammadex and neostigmine on

reversing neuromuscular blockers in pediatric patients undergoing outpatient surgical

procedures.

Detailed Description

Postoperative residual curarization (PORC)" a residual duration of action of muscle relaxants beyond the end of the operation" in postoperative patients is a succession of the presence of blocked nicotinic receptors. Even in observationally asymptomatic patients, 60-70% of these receptors can be still blocked. PORC can cause delayed recovery, hypoxia, metabolic derangement and rarely death. Cholinesterase inhibitors are traditionally used for reversal of neuromuscular blockade (NMB). Among these agents neostigmine is the most potent and selective one. Cholinesterase inhibitors have multisystemic side effects. Since these agents are not selective to nicotinic receptors and also stimulate the muscarinic system, there can be quite a few serious adverse effects as follows: Bradycardia, QT lengthening, bronchoconstriction, hypersalivation and increased motility. To avoid these effects, concomitant anticholinergic agents, such as atropine or glycopyrolate, are administered to the patient. The incidence of PORC is still high with the prevalence of a train-of-four (TOF) ratio of less than 0.9 found in the postoperative recovery unit. Recent studies have been able to link even low levels of residual paralysis (TOF ratio <0.9) with significant impairment of pharyngeal muscle function, hypoxic ventilatory drive and decreased respiratory function in the immediate postoperative period.

Despite the knowledge of such side effects, and despite the introduction of various new neuromuscular blocking agents (NMBA) such as rocuronium or mivacurium over the last 15 years, no significant reduction in the incidence of residual neuromuscular blockade has so far been observable.

Today, sugammadex is an alternative to the decurarization procedure, which was traditionally executed with cholinesterase inhibitors. Sugammadex a γ-cyclodextrin with a high affinity to rocuronium and other aminosteroidal NMBA that allows the rapid and complete reversal of especially rocuronium-induced neuromuscular blockade, has raised hopes to overcome the problem of residual neuromuscular blockade. Sugammadex is proved to be a safe and superior agent in NMB reversal compared to neostigmine in adults.

PORC and the muscarinic side effects are not anticipated when using sugammadex,.

Also, due to its pharmacodynamic profile, sugammadex, in combination with rocuronium, have the potential to displace succinylcholine as the "gold standard" muscle relaxant for rapid sequence induction.

The rudimentary neuromuscular junction, the variability of fibrin fibers, the differences in drug distribution and body volume in children change their neuromuscular conduction. These factors can cause prolonged recovery and increased risk of PORC. However, there is few studies in the literature concerning sugammadex administration in pediatric patients.

Conditions

Post-operative Residual Curarization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Group S

Sugammadex for reversal of steroidal neuromuscular blockers, intravenous injection ,2mg/kg

Group Type: EXPERIMENTAL

Sugammadex Injection [Bridion]

Intervention Type: DRUG

Reversal of neuromuscular blockers

Group N

Reversal of neuromuscular blockers, iv injection, 0.05 mg/kg

Group Type: ACTIVE_COMPARATOR

Neostigmine

Intervention Type: DRUG

Reversal of neuromuscular blockers

Interventions

Sugammadex Injection [Bridion]

Reversal of neuromuscular blockers

Intervention Type: DRUG

Neostigmine

Reversal of neuromuscular blockers

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥2 years and < 18 years.
• American society of anesthesiologists (ASA) status 1-3.
• patients undergoing outpatient procedures

Exclusion Criteria

• Known drug hypersensitivity.-
• History of renal or hepatic failure.
• Diseases of the neuromuscular junction.
• history of malignant hyperthermia.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Amani Gaber Mohamed,MSc

Senior registra

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed MO Hegazy, MD

Role: STUDY_DIRECTOR

Cairo University

Mohamed Ad Elramly, MD

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

Amani Ga Mohamed, MSc

Role: CONTACT

amanigabr@yahoo.com

(202)01119611061

References

Ammar AS, Mahmoud KM, Kasemy ZA. A comparison of sugammadex and neostigmine for reversal of rocuronium-induced neuromuscular blockade in children. Acta Anaesthesiol Scand. 2017 Apr;61(4):374-380. doi: 10.1111/aas.12868. Epub 2017 Feb 10.

Reference Type: BACKGROUND

PMID: 28185260 (View on PubMed)

Meretoja OA. Neuromuscular block and current treatment strategies for its reversal in children. Paediatr Anaesth. 2010 Jul;20(7):591-604. doi: 10.1111/j.1460-9592.2010.03335.x.

Reference Type: BACKGROUND

PMID: 20642658 (View on PubMed)

Other Identifiers

Reversal agents in pediatrics

Identifier Type: -

Identifier Source: org_study_id