Sugammadex Dose Finding Under Two Years Old

NCT06575036 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2308-161-1461
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective dose-finding study of sugammadex for conventional reversal of rocuronium-induced neuromuscular blockade in children under two years of age. This study will explore 50% effective dose and 95% effective dose of sugammadex for reversal of neuromuscular blockade in less than two minutes under biased coin up-and-down method.

Conditions

Neuromuscular Blockade

Keywords

Sugammadex; Children; Dose-finding study

Outcome Measures

Primary Outcomes (2)

• 50% effective dose

  Dose of sugammadex that can reverse neuromuscular blockade in 50% of patients.

  From start of sugammadex administration to 2 minute after end of administration

• 95% effective dose

  Dose of sugammadex that can reverse neuromuscular blockade in 95% of patients.

  From start of sugammadex administration to 2 minute after end of administration

Secondary Outcomes (4)

• TOF result

  From start of sugammadex administration to 2 minute after end of administration

• Residual blockade

  From start of sugammadex administration to 24 hours after end of administration

• Blood pressure

  From start of sugammadex administration to discharge from postanesthesia care unit (less than 3 hours)

• Pulse oximetry

  From start of sugammadex administration to discharge from postanesthesia care unit (less than 3 hours)

Study Arms (1)

Study group

EXPERIMENTAL

Sequential determination of dose according to previous participant's result and by chance.

Drug: Sugammadex

Interventions

Sugammadex DRUG

The starting dose of sugammadex will be 0.5mg/kg. When the dose for a patient was not effective, the dose for next patient will be increased by 0.5mg/kg. When the dose was effective, the dose for next patient will be decreased by 0.5mg/kg or maintained, with a 1:1 of allocation ratio.

Also known as: Bridion

Study group

Eligibility Criteria

• Age: Up to 23 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Childern younger than 2 years old who are scheduled to undergo surgery under general anesthesia
• American Society of Anesthesiologists Physical Status 1 or 2

You may not qualify if:

• History of hypersensitivity to rocuronium or any anesthetics
• Presence of cardiovascular or genitourinary disease
• Presence of severe renal dysfunction or in need of dialysis
• Presence of severe hepatic dysfunction or coagualtion disorder
• Current state of administration of neuromuscular blocking agent on admission to operating room
• Concurrent use of any medications that affect the activity of neuromuscular blocking agents
• History of malignant hyperthermia
• Refusal to enroll in the study by one or more parents
• Presence of any other reasons that investigator regards inappropriate to enroll in the study.

Sponsors & Collaborators

• Sang-Hwan Ji: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (6)

• Gijsenbergh F, Ramael S, Houwing N, van Iersel T. First human exposure of Org 25969, a novel agent to reverse the action of rocuronium bromide. Anesthesiology. 2005 Oct;103(4):695-703. doi: 10.1097/00000542-200510000-00007.

  PMID: 16192761 BACKGROUND

• Sorgenfrei IF, Norrild K, Larsen PB, Stensballe J, Ostergaard D, Prins ME, Viby-Mogensen J. Reversal of rocuronium-induced neuromuscular block by the selective relaxant binding agent sugammadex: a dose-finding and safety study. Anesthesiology. 2006 Apr;104(4):667-74. doi: 10.1097/00000542-200604000-00009.

  PMID: 16571960 BACKGROUND

• 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

• Meibohm B, Laer S, Panetta JC, Barrett JS. Population pharmacokinetic studies in pediatrics: issues in design and analysis. AAPS J. 2005 Oct 5;7(2):E475-87. doi: 10.1208/aapsj070248.

  PMID: 16353925 BACKGROUND

• Olutoye OA, Yu X, Govindan K, Tjia IM, East DL, Spearman R, Garcia PJ, Coulter-Nava C, Needham J, Abrams S, Kozinetz CA, Andropoulos DB, Watcha MF. The effect of obesity on the ED(95) of propofol for loss of consciousness in children and adolescents. Anesth Analg. 2012 Jul;115(1):147-53. doi: 10.1213/ANE.0b013e318256858f. Epub 2012 May 10.

  PMID: 22575569 BACKGROUND

• Stylianou M, Flournoy N. Dose finding using the biased coin up-and-down design and isotonic regression. Biometrics. 2002 Mar;58(1):171-7. doi: 10.1111/j.0006-341x.2002.00171.x.

  PMID: 11890313 BACKGROUND

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Sang-Hwan Ji, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang-Hwan Ji, M.D., Ph.D.

CONTACT

+82-2-2072-3661; jsh1@snu.ac.kr

Jung-Bin Park, M.D., Ph.D.

CONTACT

+82-2-2072-3661; jb4001@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Up-and-down dose finding method using biased coin design

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: September 15, 2024
• Primary Completion: April 30, 2025
• Study Completion: May 31, 2025
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)