otherwise healthy patients undergoing an operation necessitating general anaesthesia
Conditions
Interventions
Trade Name: Remifentanil Orion 1 mg
Pharmaceutical Form: Infusion
INN or Proposed INN: REMIFENTANIL
CAS Number: 132875-61-7
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Sponsors
Klaus Olkkola/University of Helsinki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient is 3-15 years old (body weight (15-61 kg). Patients ASA class is 1-2. Patient comes to an elective surgery which necessitates general anesthesia. Operation time is appr. 1.5-6 hours 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient has a disease or trauma affecting the state of consciousnes or encephaloelectrogram measurement. Patient comes to a head or neck surgery. Anaesthesia cannot be induced via intravenous route. The researchers cannot place the second iv-cannula. Muscle relaxant is needed. Patient or his/her guardians refuse to take part in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Our aim is to study the effects of remifentanil on the entropy measurement in paediatric patients during general anaesthesia.;Secondary Objective: 2. To evaluate the effects of surgery pain and remifentanil analgesia to surgigal pleth index (SPI) and entropy measurement and their microdeviation. 3. To evaluate the usefulnes of entropy-measurement in assessing awakening from general anaesthesia. 4. To evaluate the usefulness of target-controlled infusion -dosing during awakening period of anaesthesia. 5. To create pharmacokinetic-pharmacodynamic model for remifentanil to be used in target controlled analgesia in pediatric patients. 6. To characterise propofol-remifentanil drug interactions 7. To characterise genomic factors affecting remifentanil analgesia. 8. To characterise remifentanil induced changes in protein expression.;Primary end point(s): All the planned SPI and entropy measurements have been done.;Timepoint(s) of evaluation of this end point: 24 hours after the start of remifentanil dosing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): All the planned blood samples have been drawn.;Timepoint(s) of evaluation of this end point: 24 hours after the start of remifentanil dosing | — |
Countries
Finland
Contacts
Public ContactKlaus Olkkola
Klaus Olkkola/University of Helsinki
Outcome results
None listed