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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Pharmacokinetic-pharmacodynamic Analysis of Sugammadex in Children

Clinicaltrials.gov identifier NCT03943888

Recruitment Status Completed

First Posted May 9, 2019

Last update posted April 14, 2020

Study Description

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.

  • Condition or Disease:Neuromuscular Blockade
    Anesthesia, General
  • Intervention/Treatment: Drug: Sugammadex Injection 2mg/kg
    Drug: Sugammadex Injection 4mg/kg
    Drug: Sugammadex Injection 8mg/kg
    Drug: Neuromuscular reversal agent injection
  • Phase: Phase 2
Detailed Description

This study enrolls pediatric patients undergoing surgery under general anesthesia with need for early reversal of neuromuscular blockade, aged between 2 and 18 years old. After routine anesthetic induction with 1% propofol and 0.6mg/kg of rocuronium, maintenance of anesthesia with total intravenous anesthesia is commenced. 15 minutes after rocuronium administration, 2 or 4 or 8mg/kg of sugammadex sodium or conventional neuromuscular reversal agent is administered according to randomization table. For neuromuscular monitoring, train-of-four (TOF) count and T4/T1 ratio are monitored, with recording of the time to recovery of the T4/T1 ratio to 0.7, 0.8 and 0.9. For pharmacokinetic analysis, patient blood sample is obtained before / 2 min after rocuronium administration, before / 2min / 5min / 15min / 60min / 120min / 240min / 480min after sugammadex administration. Plasma concentration of rocuronium and sugammadex sodium are analyzed via high-performance liquid chromatography with mass spectrometric detection.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 40 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Supportive Care
  • Official Title: Pharmacokinetic-pharmacodynamic Analysis of Reversal of Rocuronium-induced Neuromuscular Blockade by Sugammadex in Children
  • Actual Study Start Date: August 2019
  • Actual Primary Completion Date: February 2020
  • Actual Study Completion Date: February 2020
Arms and interventions
Arm Intervention/treatment
Experimental: Sugammadex 2mg
Administer 2mg/kg of sugammadex 15 minutes after rocuronium administration
Drug: Sugammadex Injection 2mg/kg
Intravenous injection of 2mg/kg of sugammadex sodium 15 minutes after rocuronium administration
Experimental: Sugammadex 4mg
Administer 4mg/kg of sugammadex 15 minutes after rocuronium administration
Drug: Sugammadex Injection 4mg/kg
Intravenous injection of 4mg/kg of sugammadex sodium 15 minutes after rocuronium administration
Experimental: Sugammadex 8mg
Administer 8mg/kg of sugammadex 15 minutes after rocuronium administration
Drug: Sugammadex Injection 8mg/kg
Intravenous injection of 8mg/kg of sugammadex sodium 15 minutes after rocuronium administration
Active Comparator: Conventional reversal
Administer conventional neuromuscular reversal agent (0.02mg/kg of atropine and 0.03mg/kg of neostigmine) 15 minutes after rocuronium administration
Drug: Neuromuscular reversal agent injection
Intravenous injection of 0.02mg/kg of atropine and 0.03mg/kg of neostigmine
Outcome Measures
  • Primary Outcome Measures: 1. Neuromuscular recovery [ Time Frame: up to 30 minutes to 1 hour ]
    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.
  • Secondary Outcome Measures: 1. Plasma concentrations [ Time Frame: From anesthetic induction to 480 minutes after sugammadex administration ]
    Plasma concentrations of rocuronium and sugammadex sodium
Eligibility Criteria
  • Ages Eligible for Study: 2 to 17 Years (Child)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria: All of below

- 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

Exclusion Criteria: Any of below

- 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

Contacts and Locations
Contacts
Locations

Korea, Republic of, Jongro Gu
SNUH
Seoul

Sponsors and Collaborators

Seoul National University Hospital

Ministry of Food and Drug Safety, Korea

Investigators

Principal Investigator: Hee-Soo Kim, M.D, Ph.D. Seoul National University Hospital

More Information