Sugammadex Dose Finding Under Two Years Old

August 27, 2024 updated by: Sang-Hwan Ji

Reversal of Rocuronium-induced Neuromuscular Blockade by Sugammadex in Children Younger Than 2 Years Old: a Prospective Dose Finding Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

33

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 Contact

  • Name: Sang-Hwan Ji, M.D., Ph.D.
  • Phone Number: +82-2-2072-3661
  • Email: jsh1@snu.ac.kr

Study Contact Backup

  • Name: Jung-Bin Park, M.D., Ph.D.
  • Phone Number: +82-2-2072-3661
  • Email: jb4001@snu.ac.kr

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

  • Child

Accepts Healthy Volunteers

No

Description

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.

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: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Sequential determination of dose according to previous participant's result and by chance.
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.
Other Names:
  • Bridion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
50% effective dose
Time Frame: From start of sugammadex administration to 2 minute after end of administration
Dose of sugammadex that can reverse neuromuscular blockade in 50% of patients.
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
Dose of sugammadex that can reverse neuromuscular blockade in 95% of patients.
From start of sugammadex administration to 2 minute after end of administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TOF result
Time Frame: From start of sugammadex administration to 2 minute after end of administration
Response to train-of-four stimulation after administration of sugammadex
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
Incidence of recurarization in the postanesthesia care unit
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)
Noninvasive blood pressure after sugammadex administration measured in the operating room and postanesthesia care unit
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)
Pulse oximetry after sugammadex administration measured in the operating room and postanesthesia care unit
From start of sugammadex administration to discharge from postanesthesia care unit (less than 3 hours)

Collaborators and Investigators

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

Sponsor

Sang-Hwan Ji

Investigators

  • Principal Investigator: Sang-Hwan Ji, 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 (Estimated)

September 15, 2024

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

August 26, 2024

First Submitted That Met QC Criteria

August 26, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2308-161-1461

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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