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Anesthesia, GeneralPhase 2NCT04347486

Pharmacokinetic-pharmacodynamic Analysis of Sugammadex for Conventional Reversal in Children

A Phase 2 study testing Sugammadex Injection 2mg/kg, Sugammadex Injection 4mg/kg and Sugammadex Injection 8mg/kg in people with Anesthesia, General and Neuromuscular Blockade, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Anesthesia, General, Neuromuscular Blockade
What is being tested?
Sugammadex Injection 2mg/kg, Sugammadex Injection 4mg/kg and Sugammadex Injection 8mg/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteSouth Korea
Study dates
29 Apr 2020to 7 Dec 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • SNUH

    Seoul, Jongro Gu, 15710

Other trials in South Korea

About this study

Official title: Pharmacokinetic-pharmacodynamic Analysis of Conventional 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.

Read the detailed description

This study enrolls pediatric patients undergoing surgery under general anesthesia with need for 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. 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.

On reappearance of T2 after rocuronium administration , 2 or 4 or 8mg/kg of sugammadex sodium or conventional neuromuscular reversal agent is administered according to randomization table.

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.

Being tested
Sugammadex Injection 2mg/kg, Sugammadex Injection 4mg/kg, Sugammadex Injection 8mg/kg, Neuromuscular reversal agent injection
Keywords
Sugammadex, Pharmacokinetics, Pharmacodynamics, Pediatric anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sugammadex Injection 2mg/kgDrug

    Also called Bridion 2mg/kg

    Intravenous injection of 2mg/kg of sugammadex sodium on reappearance of T2

  • Sugammadex Injection 4mg/kgDrug

    Also called Bridion 4mg/kg

    Intravenous injection of 4mg/kg of sugammadex sodium on reappearance of T2

  • Sugammadex Injection 8mg/kgDrug

    Also called Bridion 8mg/kg

    Intravenous injection of 8mg/kg of sugammadex sodium on reappearance of T2

  • Neuromuscular reversal agent injectionDrug

    Also called Atropine and neostigmine

    Intravenous injection of 0.02mg/kg of atropine and 0.03mg/kg of neostigmine

Study groups in NCT04347486
Study groupRoleWhat they receive
Sugammadex 2mgExperimentalAdminister 2mg/kg of sugammadex on reappearance of T2 by Train-of-Four stimulation
Receives: Drug: Sugammadex Injection 2mg/kg
Sugammadex 4mgExperimentalAdminister 4mg/kg of sugammadex on reappearance of T2 by Train-of-Four stimulation
Receives: Drug: Sugammadex Injection 4mg/kg
Sugammadex 8mgExperimentalAdminister 8mg/kg of sugammadex on reappearance of T2 by Train-of-Four stimulation
Receives: Drug: Sugammadex Injection 8mg/kg
Conventional reversalActive comparatorAdminister conventional neuromuscular reversal agent (0.02mg/kg of atropine and 0.03mg/kg of neostigmine) on reappearance of T2 by Train-of-Four stimulation
Receives: Drug: Neuromuscular reversal agent injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neuromuscular recovery

    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.

    Measured: up to 30 minutes to 1 hour

Secondary outcomes (1)

  1. Plasma concentrations

    Plasma concentrations of rocuronium and sugammadex sodium

    Measured: From anesthetic induction to 480 minutes after sugammadex administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2020
  2. Study start29 Apr 2020
  3. Primary completion7 Dec 2021
  4. Study completion7 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04347486
Sponsor's protocol ID
2002-148-1105
Status last verified
Feb 2022
First submitted
13 Apr 2020
Last updated
10 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gijsenbergh F, Ramael S, Houwing N, van Iersel T. First human exposure of Org 25969, a novel agent to reverse the action of rocuronium bromide. Anesthesiology. 2005 Oct;103(4):695-703. doi: 10.1097/00000542-200510000-00007.

    PubMed 16192761

  • Sorgenfrei IF, Norrild K, Larsen PB, Stensballe J, Ostergaard D, Prins ME, Viby-Mogensen J. Reversal of rocuronium-induced neuromuscular block by the selective relaxant binding agent sugammadex: a dose-finding and safety study. Anesthesiology. 2006 Apr;104(4):667-74. doi: 10.1097/00000542-200604000-00009.

    PubMed 16571960

  • Sparr HJ, Vermeyen KM, Beaufort AM, Rietbergen H, Proost JH, Saldien V, Velik-Salchner C, Wierda JM. Early reversal of profound rocuronium-induced neuromuscular blockade by sugammadex in a randomized multicenter study: efficacy, safety, and pharmacokinetics. Anesthesiology. 2007 May;106(5):935-43. doi: 10.1097/01.anes.0000265152.78943.74.

    PubMed 17457124

  • Ploeger BA, Smeets J, Strougo A, Drenth HJ, Ruigt G, Houwing N, Danhof M. Pharmacokinetic-pharmacodynamic model for the reversal of neuromuscular blockade by sugammadex. Anesthesiology. 2009 Jan;110(1):95-105. doi: 10.1097/ALN.0b013e318190bc32.

    PubMed 19104176

  • Won YJ, Lim BG, Lee DK, Kim H, Kong MH, Lee IO. Sugammadex for reversal of rocuronium-induced neuromuscular blockade in pediatric patients: A systematic review and meta-analysis. Medicine (Baltimore). 2016 Aug;95(34):e4678. doi: 10.1097/MD.0000000000004678.

    PubMed 27559972

  • Ji SH, Huh KY, Oh J, Jeong HJ, Jang YE, Kim EH, Lee JH, Kim JT, Kim HS. Conventional reversal of rocuronium-induced neuromuscular blockade by sugammadex in Korean children: pharmacokinetics, efficacy, and safety analyses. Front Pharmacol. 2023 Apr 13;14:1127932. doi: 10.3389/fphar.2023.1127932. eCollection 2023.

    PubMed 37124204

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sugammadex Injection 2mg/kg, Sugammadex Injection 4mg/kg and Sugammadex Injection 8mg/kg in people with Anesthesia, General and Neuromuscular Blockade, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neuromuscular recovery (time frame: up to 30 minutes to 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04347486, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.

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