Pharmacokinetic-pharmacodynamic Analysis of Sugammadex in Children

October 20, 2022 updated by: Hee-Soo Kim, Seoul National University Hospital

Pharmacokinetic-pharmacodynamic Analysis of Reversal of Rocuronium-induced Neuromuscular Blockade by Sugammadex in Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Other Names:
  • Bridion 2mg/kg
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
Other Names:
  • Bridion 4mg/kg
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
Other Names:
  • Bridion 8mg/kg
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
Other Names:
  • Atropine and neostigmine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 30 minutes to 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Concentrations
Time Frame: From anesthetic induction to 480 minutes after sugammadex administration
Plasma concentrations of rocuronium and sugammadex sodium
From anesthetic induction to 480 minutes after sugammadex administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Ministry of Food and Drug Safety, Korea

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2019

Primary Completion (Actual)

February 20, 2020

Study Completion (Actual)

February 20, 2020

Study Registration Dates

First Submitted

May 6, 2019

First Submitted That Met QC Criteria

May 8, 2019

First Posted (Actual)

May 9, 2019

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

October 20, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1904-149-1029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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