Pharmacokinetic-pharmacodynamic Analysis of Sugammadex in Children
1 other identifier
interventional
40
1 country
1
Brief Summary
This study administers sugammadex sodium to pediatric patients under general anesthesia with rocuronium. Pharmacokinetic and pharmacodynamic analysis are performed based on plasma concentration of sugammadex sodium and monitoring of neuromuscular blockade.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2019
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2019
CompletedFirst Posted
Study publicly available on registry
May 9, 2019
CompletedStudy Start
First participant enrolled
August 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2020
CompletedResults Posted
Study results publicly available
November 14, 2022
CompletedNovember 14, 2022
October 1, 2022
6 months
May 6, 2019
October 20, 2022
October 20, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neuromuscular Recovery
Time to recovery of train-of-four T4/T1 ratio to 90% after sugammadex sodium or neuromuscular reversal agent administration up to 30 minutes to 1 hour.
up to 30 minutes to 1 hour
Secondary Outcomes (1)
Plasma Concentrations
From anesthetic induction to 480 minutes after sugammadex administration
Study Arms (4)
Sugammadex 2mg
EXPERIMENTALAdminister 2mg/kg of sugammadex 15 minutes after rocuronium administration
Sugammadex 4mg
EXPERIMENTALAdminister 4mg/kg of sugammadex 15 minutes after rocuronium administration
Sugammadex 8mg
EXPERIMENTALAdminister 8mg/kg of sugammadex 15 minutes after rocuronium administration
Conventional reversal
ACTIVE COMPARATORAdminister conventional neuromuscular reversal agent (0.02mg/kg of atropine and 0.03mg/kg of neostigmine) 15 minutes after rocuronium administration
Interventions
Intravenous injection of 2mg/kg of sugammadex sodium 15 minutes after rocuronium administration
Intravenous injection of 4mg/kg of sugammadex sodium 15 minutes after rocuronium administration
Intravenous injection of 8mg/kg of sugammadex sodium 15 minutes after rocuronium administration
Intravenous injection of 0.02mg/kg of atropine and 0.03mg/kg of neostigmine
Eligibility Criteria
You may qualify if:
- Pediatric patients undergoing surgery under general anesthesia with requirement of early reversal of neuromuscular blockade
- Aged between 2 and 17
- American Society of Anesthesiologists Physical Status Classification 1 and 2
You may not qualify if:
- One or more legal guardian declines to enroll in the study
- History of hypersensitivity to any anesthetic agents including rocuronium
- Presence of underlying cardiovascular or genitourinary disease
- Under usage of neuromuscular blocking agents before surgery
- Under usage of drugs influencing the effect of neuromuscular blocking agents
- History of malignant hyperthermia
- Anticipation of massive hemorrhage during surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SNUH
Seoul, Jongro Gu, 15710, South Korea
Related Publications (5)
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: 16192761BACKGROUNDSorgenfrei 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: 16571960BACKGROUNDSparr HJ, Vermeyen KM, Beaufort AM, Rietbergen H, Proost JH, Saldien V, Velik-Salchner C, Wierda JM. Early reversal of profound rocuronium-induced neuromuscular blockade by sugammadex in a randomized multicenter study: efficacy, safety, and pharmacokinetics. Anesthesiology. 2007 May;106(5):935-43. doi: 10.1097/01.anes.0000265152.78943.74.
PMID: 17457124BACKGROUNDPloeger BA, Smeets J, Strougo A, Drenth HJ, Ruigt G, Houwing N, Danhof M. Pharmacokinetic-pharmacodynamic model for the reversal of neuromuscular blockade by sugammadex. Anesthesiology. 2009 Jan;110(1):95-105. doi: 10.1097/ALN.0b013e318190bc32.
PMID: 19104176BACKGROUNDWon YJ, Lim BG, Lee DK, Kim H, Kong MH, Lee IO. Sugammadex for reversal of rocuronium-induced neuromuscular blockade in pediatric patients: A systematic review and meta-analysis. Medicine (Baltimore). 2016 Aug;95(34):e4678. doi: 10.1097/MD.0000000000004678.
PMID: 27559972BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Sang-Hwan Ji
- Organization
- Seoul National University Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Hee-Soo Kim, M.D, Ph.D.
Seoul National University Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, Professor
Study Record Dates
First Submitted
May 6, 2019
First Posted
May 9, 2019
Study Start
August 12, 2019
Primary Completion
February 20, 2020
Study Completion
February 20, 2020
Last Updated
November 14, 2022
Results First Posted
November 14, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share