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NCT Number: NCT06575036

Sugammadex Dose Finding Under Two Years Old

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.

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Key information

Age range

Up to 23 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sugammadex

Drug

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. Residual blockade

    Time frame: From start of sugammadex administration to 24 hours after end of administration

    Incidence of recurarization in the postanesthesia care unit

  3. 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

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jung-Bin Park, M.D., Ph.D.

CONTACT

[email protected]

+82-2-2072-3661

Sang-Hwan Ji, M.D., Ph.D.

CONTACT

[email protected]

+82-2-2072-3661

Sponsors and collaborators

Lead sponsor

Sang-Hwan Ji

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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