Effect of Sugammadex vs. Neostigmine/Glycopyrrolate on Pediatric Emergence Delirium in Sevoflurane-rocuronium Anesthesia

NCT03229486 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: PusanNUYH
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effect of sugammadex vs. a conventional acetylcholinesterase inhibitor, neostigmine on emergence delirium (ED) during sevoflurane-rocuronium anesthesia in pediatric patients Additionally, the efficacy features of sugammadex compared to neostigmine will be examined by measuring the time from start of administration of reversal agents to recovery of train-of-four (TOF) ratio to 0.7, 0.8, and 0.9. Although the etiology of ED remains unclear, a sense of suffocation or breathing difficulty during emergence from anesthesia has been suggested as a possible cause. Thus, reversal of neuromuscular blockade with sugammadex in pediatric patients maintained with sevoflurane-rocuronium anesthesia may decrease ED due to its faster reversal of neuromuscular blockade and decreased possibility of residual blockade.

Conditions

Emergence Delirium

Keywords

emergence delirium; tonsillectomy

Outcome Measures

Primary Outcomes (1)

• Pediatric Anesthesia Emergence Delirium Score

  Maximum Pediatric Anesthesia Emergence Delirium (PAED) score after arrival in the PACU.Higher values represent more emergence delirium (worse) PAED Score is represented with total PAED score summed up of subscales. The total score is reported and it ranges from 0 to 20. Higher score means worse state.

  within 30 minutes after arrival at post-anesthesia care unit (PACU)

Secondary Outcomes (6)

• Time Recovery of TOF Ratio to 0.7

  Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.7, assessed up to 60 minutes

• Time to Regular Breathing

  time from administration of reversal agent to time of deep, regular breathing, assessed up to 60 minutes

• Time to Awakening

  time from administration of reversal agent to time of eye opening or child showing purposeful movements, assessed up to 60 minutes

• Time to Extubation

  time from administration of reversal agent to time of tracheal extubation, assessed up to 60 minutes

• Time Recovery of TOF Ratio to 0.8

  Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.8, assessed up to 60 minutes

Study Arms (2)

Sugammadex Injection [Bridion]

EXPERIMENTAL

reversal of neuromuscular blockade with sugammadex

Drug: Sugammadex Injection [Bridion]

Neostigmine+Glycopyrronium

ACTIVE COMPARATOR

reversal of neuromuscular blockade with neostigmine \& glycopyrrolate

Drug: Neostigmine+Glycopyrronium

Interventions

Sugammadex Injection [Bridion] DRUG

Return to T2 point (two contractions) on TOF device is replied by iv 2 mg/kg sugammadex administration, contained in a blinded syringe.

Also known as: Sugammadex

Sugammadex Injection [Bridion]

Neostigmine+Glycopyrronium DRUG

Return to T2 point (two contractions) on TOF device is replied by iv 0.06 mg/kg neostigmine and 0.005 mg/kg glycopyrrolate administration, contained in a blinded syringe.

Also known as: Neostigmine

Neostigmine+Glycopyrronium

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• American Society of Anesthesiologist (ASA) physical status I or II, preschool children scheduled for an elective tonsillectomy with or without adenoidectomy will be included in the study.

You may not qualify if:

• Patients will be excluded in cases of emergency surgery, developmental, psychological, cognitive or communication disorders, known or suspected neuromuscular disorders that may impair neuromuscular blockade, significant renal or hepatic dysfunction, coagulation disorders, family history of malignant hyperthermia, allergy to any of the drugs included in the study protocol, or usage of medication known to interact with rocuronium or sugammadex.

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

Related Publications (3)

• Plaud B, Meretoja O, Hofmockel R, Raft J, Stoddart PA, van Kuijk JH, Hermens Y, Mirakhur RK. Reversal of rocuronium-induced neuromuscular blockade with sugammadex in pediatric and adult surgical patients. Anesthesiology. 2009 Feb;110(2):284-94. doi: 10.1097/ALN.0b013e318194caaa.

  PMID: 19194156 BACKGROUND

• Locatelli BG, Ingelmo PM, Emre S, Meroni V, Minardi C, Frawley G, Benigni A, Di Marco S, Spotti A, Busi I, Sonzogni V. Emergence delirium in children: a comparison of sevoflurane and desflurane anesthesia using the Paediatric Anesthesia Emergence Delirium scale. Paediatr Anaesth. 2013 Apr;23(4):301-8. doi: 10.1111/pan.12038. Epub 2012 Oct 9.

  PMID: 23043512 BACKGROUND

• Pieters BJ, Penn E, Nicklaus P, Bruegger D, Mehta B, Weatherly R. Emergence delirium and postoperative pain in children undergoing adenotonsillectomy: a comparison of propofol vs sevoflurane anesthesia. Paediatr Anaesth. 2010 Oct;20(10):944-50. doi: 10.1111/j.1460-9592.2010.03394.x. Epub 2010 Aug 24.

  PMID: 20735801 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium

Interventions

Sugammadex; Neostigmine

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Professor
• Organization: Pusan National University Yangsan Hospital

anesktk@pusan.ac.kr

0553602756

Study Officials

• Tae-Kyun Kim, MD, PhD

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 25, 2017
• Study Start: March 1, 2017
• Primary Completion: July 30, 2019
• Study Completion: December 30, 2019
• Last Updated: March 17, 2020
• Results First Posted: March 17, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)