Clinical trial NCT06575036: Sugammadex Dose Finding Under Two Years Old
Official title: Reversal of Rocuronium-induced Neuromuscular Blockade by Sugammadex in Children Younger Than 2 Years Old: a Prospective Dose Finding Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Neuromuscular Blockade
Keywords: Sugammadex
Children
Dose-finding study
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 33
Sex: ALL
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Up-and-down dose finding method using biased coin design
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: 50% effective dose
timeFrame: From start of sugammadex administration to 2 minute after end of administration
measure: 95% effective dose
timeFrame: From start of sugammadex administration to 2 minute after end of administration
Secondary outcomes:
measure: TOF result
timeFrame: From start of sugammadex administration to 2 minute after end of administration
measure: Residual blockade
timeFrame: From start of sugammadex administration to 24 hours after end of administration
measure: Blood pressure
timeFrame: From start of sugammadex administration to discharge from postanesthesia care unit (less than 3 hours)
measure: Pulse oximetry
timeFrame: From start of sugammadex administration to discharge from postanesthesia care unit (less than 3 hours)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Sang-Hwan Ji, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.