This is a CT including only healthy volunteers. The aim of the study is to investigate the effect of a commonly used anesthetic drug in clinical concentrations on nociceptive and antinociceptive mechanisms.
Conditions
Interventions
Trade Name: Disoprivan 1%
Pharmaceutical Form: Emulsion for infusion
INN or Proposed INN: PROPOFOL
CAS Number: 2078-54-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Con
Sponsors
Charité, Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Informed consent - Age between 18-60 years - No participation in other studies Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Any light or severe disease - Especially, even in the lightest cases: infection of the respiratory system, muscular diseases, diseases of the CNS, chronic pain diseases, drug or medication abuse - Claustrophobia - Conditions with an increased risk of aspiration, expecially adipositas (BMI>=30kg/m²) - pregnancy or lactation - history or family history of malignant hyperthermia - history or family history of allergic reactions against propofol, remifentanil, soja, latex - Placement in an institution on official authorities order or judicial order - implants, especially pacemakers, cardioverters, cochlea implants, insulin pumps, nerve stimulators, vascular clips, cava filters, metal splints, screws, wires, plates - extensive or looped tattoos, piercings, other ferromagnetic ornaments which cannot be removed - lack of consent to the storage and transmission of data within the scope of the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To demonstrate a dose-dependency of BOLD-responses in the brain following noxious stimulation for propofol and remifentanil;Secondary Objective: 2. To demonstrate an influence of propofol and remifentanil on the functional connectivity between brain areas following noxious stimulation 3. To demonstrate an effect of propofol and remifentanil on the diffuse noxious inhibitory controls (DNIC) 4. To investigate and validate surrogate parameters for the noxious perception of an unconscious subject to provide for a monitoring tool for clinical anesthesia and intensive care medicine;Primary end point(s): We hypothesize an influence of the anesthetic on the nociceptive structures. Therefore we anticipate under influence of the anesthetic changes in the function of different brain structures visualized using the fMRI, changes in the EEG and changes in responses of nociceptive reflexes. Changes that can be detected at the loss of consciousness can possibly be related to the conscious perception of pain. ;Timepoint(s) of evaluation of this end point: During anesthesia, each subject is tested repeatedly for changes in the nociceptive responses. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end points are changes in fMRI-connectivity of pain related signals under anesthesia and changes in clinical surrogates for nociception under anesthesia.;Timepoint(s) of evaluation of this end point: During anesthesia, each subject is tested repeatedly for changes in the nociceptive responses. | — |
Countries
Germany
Contacts
Public ContactFalk von Dincklage
Charité - Universitätsmedizin Berlin
Outcome results
None listed