EUCTR2020-000595-37-CZ
Active, not recruiting
Phase 1
Pharmacokinetics and pharmacodynamics of levobupivacaine during continuous caudal epidural analgesia in newborns - LEVO
Fakultní nemocnice v Motole0 sites60 target enrollmentStarted: June 25, 2020Last updated:
ConditionsThe primary aim of study is to determine PK and PD of levobupivacaine in newborns (premature included). And discover or decline of LA cumulation.The secondary aim of the study is to obtain enough information about decrease of opiate doses, occurrence of side effects of c-CELA, occurrence of tolerance, hyperalgesia and withdrawal syndrome associated with opiates.Therapeutic area: Health Care [N] - Population Characteristics [N01]
DrugsCHIROCAINE 5MG/ML
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Fakultní nemocnice v Motole
- Enrollment
- 60
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Subjects fulfilling following criteria will be enrolled into the study during the 2 years time period.
- •?Obtained informed consent of parent(s)/legal representative(s)
- •?Age younger than 45th week of PMA
- •?Previous or planned operation with great demand on POPM
- •?Other diseases demanding great POPM (even without any need of surgery)
- •?Vital functions of the patient will be stable and there will be no suspicion, that patient current condition might be worsen by insertion of c\-CELA (every patient will be discussed with attending physician )
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
Exclusion Criteria
- •?Decline of informed consent by parent(s) legal representative
- •?Age older than 45th week of PMA
- •?Congenital malformation of caudal part of spine ( spina bifida oculta , meningocele, meningomyelocele)
- •?Disease or congenital malformation significantly restricting liver functions (Elevation of liver enzymes more than twice above the physiological range of the corresponding PMA)
- •?Disease or congenital malformation significantly restricting kidney functions (Elevation of urea and creatinine enzymes more than twice above the physiological range of the corresponding PMA)
- •?Clinical condition, which doesn’t long\-term POPM
- •? Patients with proven withdrawal syndrome caused by opiate administration
- •?High risk of bleeding during insertion (coagulopathy)
- •?Severe anemia, which would lead to blood transfusion due to taking of blood samples
Investigators
Similar Trials
Active, not recruiting
Not Applicable
Evaluation of pharmacokinetics of levobupivacaine and ropivacaine during epidural infusion - NDMajor surgeryMedDRA version: 9.1Level: SOCClassification code 10042613EUCTR2010-019393-32-ITOSPEDALE POLICLINICO S. MATTEO
Not yet recruiting
Phase 4
Pharmacokinetics of 0.25% levobupivacaine with adrenaline following caudal epidural administration in childrePharmacokinetics in children receiving LevobupivacaineOther -ACTRN12606000428561Royal Childrens' Hospital50
Completed
Not Applicable
Pharmacokinetic and Pharmacodynamic study of nab-Paclitaxel and solvent-based Paclitaxel in patients with metastatic or recurrent gastric cancerMetastatic or recurrent gastric cancerJPRN-UMIN000030277Shizuoka Cancer Center24
Completed
Not Applicable
Effects of levobupivacaine containing low molecular weight dextran on transversus abdominis plane block and rectus sheath blockabdominal diseases receiving laparoscopic surgeryJPRN-UMIN000008830Osaka City University Medical School Department of Anesthesiology20
Not yet recruiting
Phase 4
The Pharmacokinetic/Pharmacodynamic Study of Biapenem combination with Fosfomycin sodium against Acinetobacter baumannii infection in Thai Critically IllCritically ill patients who suspected Gram negative bacteria infection.Pharmacokinetic/Pharmacodynamic Study,Acinetobacter baumannii,Critically Ill patientsTCTR20180222002Faculty of Graduate Studies, Mahidol University20