PKPD of Rocuronium and Sugammadex Profile in Pediatric Patients
NCT04851574 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 37
Last updated 2021-04-20
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.
Conditions
- General Anesthetic Drug Adverse Reaction
Interventions
- DRUG
-
Sugammadex Injection
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.
Sponsors & Collaborators
-
Poznan University of Medical Sciences
lead OTHER
Principal Investigators
-
Alicja Bartkowska-Sniatkowska, MD PhD · Department of Pediatric Anesthesiology and Intensive Care
Eligibility
- Min Age
- 2 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-10-27
- Primary Completion
- 2020-01-20
- Completion
- 2020-01-29
Countries
- Poland
Study Locations
More Related Trials
-
Comparison of Sugammadex Administered at 1-2 Post Tetanic Counts (PTCs) or Better With Neostigmine Administered as Per Standard of Care to Reverse Rocuronium-Induced Neuromuscular Blockade in Adults Undergoing Elective Open Abdominal Procedure (19.4.334) (P05774)
NCT00675792 ·Status: COMPLETED ·Phase: PHASE3
-
A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part B: Caucasian Participants (P05971)
NCT00552617 ·Status: COMPLETED ·Phase: PHASE2
-
Dexmetomidine in Children Undergoing General Anaesthesia
NCT03923075 ·Status: COMPLETED ·Phase: NA
-
Rapid Sequence Induction: Succinyl Choline vs Rocuronium After Pretreatment With Dexmedetomidine
NCT04709315 ·Status: UNKNOWN ·Phase: PHASE3
-
Effect of Sedative and Anxiolytic Premedication on Children Experience After General Anesthesia
NCT05681572 ·Status: RECRUITING ·Phase: PHASE3
-
Role of Sugammadex and Neostigmine for Recovery From Rocuronium
NCT06432621 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Comparison of 2.0 mg/kg Sugammadex and Neostigmine at Reappearance of T2 in Chinese and European Subjects (Study 19.4.324)(P05768AM1)(COMPLETED)
NCT00825812 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Perineural Dexmedetomidine on the ED50 Ropivacaine for Brachial Plexus Blocks in Pediatric Patients: a Randomized Trial
NCT02781246 ·Status: UNKNOWN ·Phase: PHASE4
-
Clinical Study of Oral Midazolam Combined With Esketamine Administered Intranasally for Pediatric Preoperative Sedation
NCT05925283 ·Status: UNKNOWN ·Phase: PHASE4
-
Intravenous Dexmedetomidine as an Adjuvant to Locoregional Anesthesia in Pediatric Surgery
NCT06736483 ·Status: RECRUITING ·Phase: PHASE2
-
Intranasal Versus Intravenous Drug in Painful Procedure for Outpatient Oncologic Participants
NCT04621110 ·Status: UNKNOWN ·Phase: PHASE3
-
Different Premedication in Pediatric Patients
NCT04266340 ·Status: COMPLETED ·Phase: NA
-
Use of Dexmedetomidine in Children Undergoing Cardiac Surgery
NCT02375243 ·Status: COMPLETED ·Phase: PHASE2
-
Combination With Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients
NCT04135014 ·Status: UNKNOWN ·Phase: PHASE4
-
The Study is Being Conducted to Evaluate the Efficacy and Safety of Dexmedetomidine Hydrochloride Microneedles for Preoperative Sedation in Children
NCT07168720 ·Status: RECRUITING ·Phase: PHASE2
-
The Clinical Research of Intranasal Dexmedetomidine Used in Plastic Surgery of Children
NCT02222636 ·Status: UNKNOWN ·Phase: PHASE4
-
The Clinical Effect of Sugammadex Sodium (Domestic) for Antagonizing Neuromuscular Blockade After Thoracic Surgery
NCT06334562 ·Status: RECRUITING ·Phase: NA
-
Pharmacokinetics-pharmacodynamics and Safety of Dexmedetomidine in Children
NCT04027829 ·Status: COMPLETED ·Phase: PHASE2
-
Comparison of Sugammadex With Neostigmine as Reversal Agents for Rocuronium at Reappearance of T2 (Study P06101)
NCT01050543 ·Status: COMPLETED ·Phase: PHASE3
-
Intranasal Dexmedetomidine Premedication in Children
NCT02250703 ·Status: COMPLETED ·Phase: PHASE3
-
Comparative Efficacy and Safety of Sugammadex and Neostigmine
NCT04997759 ·Status: UNKNOWN ·Phase: NA
-
Intranasal Midazolam in Children as a Pre-Operative Sedative
NCT02314546 ·Status: COMPLETED ·Phase: PHASE4
-
a Phase III Trial of Safety and Efficacy of Premedication With Dexmedetomidine and Midazolam in Pediatric Patients
NCT04356638 ·Status: RECRUITING ·Phase: PHASE3
-
Propofol vs. Nasal Dexmedetomidine in Pediatric Agitation and Delirium
NCT06466915 ·Status: COMPLETED ·Phase: PHASE4
-
The Effects of Dexmedetomidine on the Heart Beat During Elective Surgery in Children
NCT02353169 ·Status: COMPLETED ·Phase: PHASE4