Status:
COMPLETED
PKPD of Rocuronium and Sugammadex Profile in Pediatric Patients
Lead Sponsor:
Poznan University of Medical Sciences
Conditions:
General Anesthetic Drug Adverse Reaction
Eligibility:
All Genders
2-18 years
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 (ro...
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 suga...
Eligibility Criteria
Inclusion
- 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
Exclusion
- ASA III and more
- age below 2 yrs
- lack of consent
- allergy to studied drugs
- less than 30 minutes of relaxation required
Key Trial Info
Start Date :
October 27 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 29 2020
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04851574
Start Date
October 27 2017
End Date
January 29 2020
Last Update
April 20 2021
Active Locations (1)
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1
Alicja Bartkowska-Sniatkowska
Poznan, Grand Poland, Poland, 60-572