Different Reversal Agents in Pediatric Day-case Cancer Surgery

Post-operative Residual Curarization Clinical Trial

Official title:

Sugammadex Versus Neostigmine in Pediatric Day-case Cancer Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03996655
• Other study ID #: Reversal agents in pediatrics
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 2019
• Est. completion date: October 2019

Study information

• Verified date: June 2019
• Source: National Cancer Institute, Egypt
• Contact: Amani Ga Mohamed, MSc
• Phone: (202)01119611061
• Email: amanigabr[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: October 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Post-operative Residual Curarization

Intervention

Drug:
• Sugammadex Injection [Bridion]
Reversal of neuromuscular blockers
• Neostigmine
Reversal of neuromuscular blockers

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery time	time from neostigmine or sugammadex administration until recovery of the TOF ratio to 0.9%	time from reversal administration until TOF ratio reaches0.9%, ranging from 1 to 2.5 minutes, measured withThe train-of-four (TOF) equipment working with the nerve-muscle acceleromyometry principle (TOF Draeger Medical Systems, Inc.16 Electronic Avenue,
Secondary	extubation time	time from neuromuscular blocker administration to extubation	time from muscle relaxant administration until extubation,extubation will be performed based on clinical criteria extubation timeis estimated to range from 50 to 55 minutes