neurosurgical pediatric patients. MedDRA version: 9.1 Level: LLT Classification code 10061268 Term: Malignant nervous system neoplasm
Conditions
Interventions
Trade Name: ULTIVA*IV 5FL 5MG
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Remifentanil
CAS Number: 132539-07-2
Concentration unit: µg microgram(s)
Concentration type: equal
Concen
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: therapy in neurosurgical pediatric patients Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: the aim of this study is to evaluate the effects of Ketamine and Remifentanyl administred in target-controlled infusion on the cerebral hemodynamics of neurosurgical pediatric patients.;Secondary Objective: ;Primary end point(s): The use of a target-controlled infusion of ketamine is not associated with adverse effects on cerebral hemodynamic in neurosurgical pediatric patients. A two-fold increase in Ketamine plasma concentration do not involve a significant change for intracranial pressure, cerebral perfusion pressure, and mean velocity of middle cerebral artery. | — |
Countries
Italy
Outcome results
None listed