NCT04851574

Brief Summary

The aim of the study is to assess the pharmacokinetic and pharmacodynamic properties of rocuronium and sugammadex and their clinical effect in the terms of both the relaxation of paralysed muscles (rocuronium) and the reversal of neuromuscular blockade (sugammadex) in children over 2 years of age undergoing general anesthesia for surgical procedures needing muscle relaxation for more than 30 minutes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 20, 2021

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

2.2 years

First QC Date

March 7, 2021

Last Update Submit

April 18, 2021

Conditions

General Anesthetic Drug Adverse Reaction

Keywords

General anesthesiaChildren

Outcome Measures

Primary Outcomes (1)

  • Recovery of muscular contraction following sugammadex injection

    Recovery of muscular contraction following sugammadex in reversal of neuromuscular blockade in children

    up to 24 hours

Secondary Outcomes (6)

  • Sugammadex serum concentration [ng/ml]

    up to 24 hours

  • Heart rate [beats per minute]

    up to 24 hours

  • Systolic blood pressure [mmHg]

    up to 24 hours

  • Diastolic blood pressure [mmHg]

    up to 24 hours

  • Blood Oxygen Saturation [percent]

    up to 24 hours

  • +1 more secondary outcomes

Study Arms (3)

Group I with dose of Sugammadex of 0.5 Mg/kg

After general anesthesia children received one dose of 0.5 Mg/kg of Sugammadex to reverse neuromuscular blockade.

Drug: Sugammadex Injection

Group II with dose of Sugammadex of 1.0 Mg/kg

After general anesthesia children received one dose of 1.0 Mg/kg of Sugammadex to reverse neuromuscular blockade.

Drug: Sugammadex Injection

Group III with dose of Sugammadex of 2.0 Mg/kg

After general anesthesia children received one dose of 2.0 Mg/kg of Sugammadex to reverse neuromuscular blockade.

Drug: Sugammadex Injection

Interventions

Sugammadex InjectionDRUG

Sugammadex was administered in the dose of 0.5 Mg/kg or 1.0 Mg/kg or 2.0 Mg/kg to reverse neuromuscular blockade.

Also known as: Sugammadex 100Mg/ml Intravenous Solution
Group I with dose of Sugammadex of 0.5 Mg/kgGroup II with dose of Sugammadex of 1.0 Mg/kgGroup III with dose of Sugammadex of 2.0 Mg/kg

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children, aged 2-18 yrs, assessed according to American Society of Anesthesiologists (ASA) scale as I or II, qualified to surgical procedures requiring muscle relaxation for more than 30 minutes, and undergoing general anesthesia

You may qualify if:

  • age 2-18 years
  • ASA I-II
  • qualification to surgival procedures requiring muscle relaxation for more than 30 minutes
  • parental consent of children below 16 yrs and parental and child's consent if child was older than 16 yrs of age
  • Bioethical Commission approvement No 161/17

You may not qualify if:

  • ASA III and more
  • age below 2 yrs
  • lack of consent
  • allergy to studied drugs
  • less than 30 minutes of relaxation required

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alicja Bartkowska-Sniatkowska

Poznan, Grand Poland, 60-572, Poland

Location

Related Publications (1)

  • Grzeskowiak M, Bienert A, Wiczling P, Malec M, Grzelak J, Jarosz K, Ber J, Ksiazkiewicz M, Rosada-Kurasinska J, Grzeskowiak E, Bartkowska-Sniatkowska A. Population Pharmacokinetic-Pharmacodynamic Modeling and Probability of Target Attainment Analysis of Rocuronium and Sugammadex in Children Undergoing Surgery. Eur J Drug Metab Pharmacokinet. 2023 Jan;48(1):101-114. doi: 10.1007/s13318-022-00809-1. Epub 2022 Dec 8.

    PMID: 36477706DERIVED

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Study Officials

  • Alicja Bartkowska-Sniatkowska, MD PhD

    Department of Pediatric Anesthesiology and Intensive Care

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

March 7, 2021

First Posted

April 20, 2021

Study Start

October 27, 2017

Primary Completion

January 20, 2020

Study Completion

January 29, 2020

Last Updated

April 20, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

PK and PD data (concentration/effect/time profiles) of individuals will be available

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
The data will be available in 4-6 months and available for 5 years
Access Criteria
Scientists

Locations

PL(1)