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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex Injection | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of muscular contraction following sugammadex injection | Recovery of muscular contraction following sugammadex in reversal of neuromuscular blockade in children | up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Sugammadex serum concentration [ng/ml] | Different doses of Sugammadex have influence on the pharmacokinetic and pharmacodynamic profile | up to 24 hours |
| Heart rate [beats per minute] | Measurement of the heart rate during and after anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Alicja Bartkowska-Sniatkowska, MD PhD | Department of Pediatric Anesthesiology and Intensive Care | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alicja Bartkowska-Sniatkowska | Poznan | Grand Poland | 60-572 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36477706 | Derived | 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. |
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PK and PD data (concentration/effect/time profiles) of individuals will be available
The data will be available in 4-6 months and available for 5 years
Scientists
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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|
| up to 24 hours |
| Systolic blood pressure [mmHg] | Measurement of the systolic blood pressure during and after anesthesia | up to 24 hours |
| Diastolic blood pressure [mmHg] | Measurement of the diastolic blood pressure during and after anesthesia | up to 24 hours |
| Blood Oxygen Saturation [percent] | Measurement of the blood oxygen saturation during and after anesthesia | up to 24 hours |
| Train-of-four monitoring | Standard practice evaluation of muscle strength during anesthesia | through study completion |
| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |