General Anesthetic Drug Adverse ReactionNCT04851574
PKPD of Rocuronium and Sugammadex Profile in Pediatric Patients
An observational study of General Anesthetic Drug Adverse Reaction, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- General Anesthetic Drug Adverse Reaction
- What is being tested?
- Sugammadex Injection
- Type of treatment
- Injection or infusion
- How many people
- 37 participants
- Where
- 1 sitePoland
- Study dates
- 27 Oct 2017to 29 Jan 2020
- Phase
- Observational
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- ASA III and more
- age below 2 yrs
- lack of consent
- allergy to studied drugs
- less than 30 minutes of relaxation required
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimization of Rocuronium and Sugammadex Dosing Based on Their Pharmacokinetic and Pharmacodynamic (PKPD) Profile in Children Undergoing General Anesthesia
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.
Read the detailed description
The study group was divided into three subgroups depending on the different doses of sugammadex. Group I received dose of 0.5 Mg/kg, Group II - 1.0 Mg/kg and Group III received dose of 2 Mg/kg of sugammadex. General anesthesia was performed among all included patients at the same way. During general anesthesia monitoring of TOF - Train-of-four, was used to assess the muscle relaxation force of rocuronium as well as the reversal of neuromuscular blockade by sugammadex. For this purpose, 1.5 ml of blood samples taken 8 times, were collected to determine the PKPD of the tested drugs, according to own protocol.
- Conditions
- General Anesthetic Drug Adverse Reaction
- Being tested
- Sugammadex Injection
- Keywords
- General anesthesia, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugammadex InjectionDrug
Also called Sugammadex 100Mg/ml Intravenous Solution
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Sugammadex Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of muscular contraction following sugammadex injection
Recovery of muscular contraction following sugammadex in reversal of neuromuscular blockade in children
Measured: up to 24 hours
Secondary outcomes (6)
Sugammadex serum concentration [ng/ml]
Different doses of Sugammadex have influence on the pharmacokinetic and pharmacodynamic profile
Measured: up to 24 hours
Heart rate [beats per minute]
Measurement of the heart rate during and after anesthesia
Measured: up to 24 hours
Systolic blood pressure [mmHg]
Measurement of the systolic blood pressure during and after anesthesia
Measured: up to 24 hours
Diastolic blood pressure [mmHg]
Measurement of the diastolic blood pressure during and after anesthesia
Measured: up to 24 hours
Blood Oxygen Saturation [percent]
Measurement of the blood oxygen saturation during and after anesthesia
Measured: up to 24 hours
Train-of-four monitoring
Standard practice evaluation of muscle strength during anesthesia
Measured: through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start27 Oct 2017
- Primary completion20 Jan 2020
- Study completion29 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for General Anesthetic Drug Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnieszka Bienert, Poznan University of Medical Sciences
- Investigators
- Alicja Bartkowska-Sniatkowska, MD PhD, Study chair, Department of Pediatric Anesthesiology and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851574
- Sponsor's protocol ID
- 161/2017
- Status last verified
- Apr 2021
- First submitted
- 7 Mar 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: PK and PD data (concentration/effect/time profiles) of individuals will be available
Publications
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.
PubMed 36477706
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Rocuronium and Sugammadex Dosing Based on Their Pharmacokinetic and Pharmacodynamic (PKPD) Profile in Children Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT04851574
- Acronym / sponsor ID
- 161/2017
- Conditions
- General Anesthetic Drug Adverse Reaction
- Keywords
- General anesthesia, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 29 Jan 2020 (actual)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study group was divided into three subgroups depending on the different doses of sugammadex. Group I received dose of 0.5 Mg/kg, Group II - 1.0 Mg/kg and Group III received dose of 2 Mg/kg of sugammadex. General anesthesia was performed among all included patients at the same way. During general anesthesia monitoring of TOF - Train-of-four, was used to assess the muscle relaxation force of rocuronium as well as the reversal of neuromuscular blockade by sugammadex. For this purpose, 1.5 ml of blood samples taken 8 times, were collected to determine the PKPD of the tested drugs, according to own protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I with dose of Sugammadex of 0.5 Mg/kg | – | Drug: Sugammadex InjectionAfter general anesthesia children received one dose of 0.5 Mg/kg of Sugammadex to reverse neuromuscular blockade. |
| Group II with dose of Sugammadex of 1.0 Mg/kg | – | Drug: Sugammadex InjectionAfter general anesthesia children received one dose of 1.0 Mg/kg of Sugammadex to reverse neuromuscular blockade. |
| Group III with dose of Sugammadex of 2.0 Mg/kg | – | Drug: Sugammadex InjectionAfter general anesthesia children received one dose of 2.0 Mg/kg of Sugammadex to reverse neuromuscular blockade. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- ASA III and more
- age below 2 yrs
- lack of consent
- allergy to studied drugs
- less than 30 minutes of relaxation required
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sugammadex InjectionAlso: Sugammadex 100Mg/ml Intravenous SolutionSugammadex was administered in the dose of 0.5 Mg/kg or 1.0 Mg/kg or 2.0 Mg/kg to reverse neuromuscular blockade. | Drug | Group I with dose of Sugammadex of 0.5 Mg/kg, Group II with dose of Sugammadex of 1.0 Mg/kg, Group III with dose of Sugammadex of 2.0 Mg/kg |
Primary outcome
Recovery of muscular contraction following sugammadex injection
Time frame: up to 24 hours
Recovery of muscular contraction following sugammadex in reversal of neuromuscular blockade in children
6 secondary outcomes
Sugammadex serum concentration [ng/ml]
Time frame: up to 24 hours
Heart rate [beats per minute]
Time frame: up to 24 hours
Systolic blood pressure [mmHg]
Time frame: up to 24 hours
Diastolic blood pressure [mmHg]
Time frame: up to 24 hours
Blood Oxygen Saturation [percent]
Time frame: up to 24 hours
Train-of-four monitoring
Time frame: through study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Derived from this study: PubMed 36477706Grzeskowiak 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.
- Individual participant dataSharing planned: Yes. PK and PD data (concentration/effect/time profiles) of individuals will be available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alicja Bartkowska-Sniatkowska, MD PhD study chair
Department of Pediatric Anesthesiology and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anesthetic Drug Adverse Reaction, run by Poznan University of Medical Sciences at 1 site in Poland.
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 5 inclusion and 5 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 20 Apr 2021. 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 Poland. 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.
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?
Recovery of muscular contraction following sugammadex injection (time frame: up to 24 hours). 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 NCT04851574, which also lists 1 linked publication.
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 20 Apr 2021.