Sugammadex Dose Finding Under Two Years Old
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sugammadex.
- Who it may be relevant to
- Registry conditions: Neuromuscular Blockade. Basic parameters: up to 23 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Reversal of Rocuronium-induced Neuromuscular Blockade by Sugammadex in Children Younger Than 2 Years Old: a Prospective Dose Finding Study
Overview
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.
Detailed description
The investigators are planning to enroll 33 patients to obtain data. 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.
The investigators will also monitor incidence of any adverse events including residual blockade to evaluate safety of sugammadex in children younger than two years old.
Interventions
- Drug Sugammadex
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.
Primary outcome measures
- 50% effective dose [Time frame: From start of sugammadex administration to 2 minute after end of administration]
- 95% effective dose [Time frame: From start of sugammadex administration to 2 minute after end of administration]
Secondary outcome measures (4)
- TOF result [Time frame: From start of sugammadex administration to 2 minute after end of administration]
- Residual blockade [Time frame: From start of sugammadex administration to 24 hours after end of administration]
- Blood pressure [Time frame: From start of sugammadex administration to discharge from postanesthesia care unit (less than 3 hours)]
- Pulse oximetry [Time frame: From start of sugammadex administration to discharge from postanesthesia care unit (less than 3 hours)]
Eligibility criteria
Inclusion criteria
- Childern younger than 2 years old who are scheduled to undergo surgery under general anesthesia
- American Society of Anesthesiologists Physical Status 1 or 2
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Publications
- 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
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT06575036 · 2308-161-1461