Health TrialsbyHealthPanel

Sugammadex Dose Finding Under Two Years Old

ConditionNeuromuscular Blockade
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 23
SponsorSang-Hwan Ji

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Childern younger than 2 years old who are scheduled to undergo surgery under general anesthesia

American Society of Anesthesiologists Physical Status 1 or 2

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

33 Participants
are divided into 1 treatment group
Group A: Study groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

50% effective dose

Dose of sugammadex that can reverse neuromuscular blockade in 50% of patients.

Time frame
From start of sugammadex administration to 2 minute after end of administration
2

95% effective dose

Dose of sugammadex that can reverse neuromuscular blockade in 95% of patients.

Time frame
From start of sugammadex administration to 2 minute after end of administration

Secondary outcomes

1

TOF result

Response to train-of-four stimulation after administration of sugammadex

Time frame
From start of sugammadex administration to 2 minute after end of administration
2

Residual blockade

Incidence of recurarization in the postanesthesia care unit

Time frame
From start of sugammadex administration to 24 hours after end of administration
3

Blood pressure

Noninvasive blood pressure after sugammadex administration measured in the operating room and postanesthesia care unit

Time frame
From start of sugammadex administration to discharge from postanesthesia care unit (less than 3 hours)
4

Pulse oximetry

Pulse oximetry after sugammadex administration measured in the operating room and postanesthesia care unit

Time frame
From start of sugammadex administration to discharge from postanesthesia care unit (less than 3 hours)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sang-Hwan Ji

Lead sponsor

Seoul National University Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: