General anaesthesia in healthy subjects
Conditions
Interventions
Trade Name: Propofol Hospira 10 mg/ml emulsión para inyección y perfusión EFG
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: PROPOFOL
CAS Number: 2078-54-8
Other descriptive name: PRO
Sponsors
Consorci Mar Parc de Salut de Barcelona (Parc de Salut Mar)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1- Healthy adult volunteers of both sexes between the ages of 18 and 40 at the time of the visit. 2- Physical state ASA 1 Patients who sign informed consent indicating that they have been informed of all relevant aspects of the trial. 4- Analysis of drugs in negative urine at the screening visit. 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 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1- Cranial cutaneous or anatomical alterations. 2- Allergy to propofol, remifentanil or any of its excipients. 3 - Body mass index (BMI) 30 kg / m2. 4- Women who test positive at the screening visit, or who are breastfeeding. Women of childbearing age (considered to be fertile after menarche and to become post-menopausal permanently unless it is sterile). They should use contraception (considered highly effective, with a failure rate of less than 1%): combined estrogen and progestogen oral contraceptives, transdermal or intravaginal. Progestin hormone contraception alone or associated with inhibition of ovulation by oral, injectable or implantable route. Intrauterine device (IUD). Intrauterine system hormone releaser (IUS). Bilateral tubal occlusion, vasectomized partner, or sexual abstinence and negative test in serum or urine to be performed on the day of selection and MRI. 5- Criteria of airway or difficult ventilation, according to the criteria of the Catalan Society of Anesthesiology, Resuscitation and Therapeutics of Pain 6- Absence of accompanying adult at the end of the study. 7- Presence of cardiac pacemakers, other electronic devices or strange ferromagnetic targets in vulnerable locations of the organism, which contraindicate the performance of MRI. 8- Background or present presence of claustrophobia. Or subjects who can not stand still for more than 25 minutes. 9- Participation in some clinical research within 3 months prior to administration of the drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To develop a system for monitoring the effect of anesthetics on consciousness and pain, based on synchronous changes in functional neuroimaging, EEG and clinical responses.;Secondary Objective: - To analyze the changes produced in the cortical connectivity map during induction of anesthesia to understand the process of "anteriorization". - To know more precisely the neural circuits involved in propofol-induced sleep. - To study if the application of a known pain stimulus modifies in some way (clinical, EEG or by MR) the LOC that has just been reached. - Establish propofol dosage guidelines adjusted for each subject, studying whether they reach the LOC at "sedative" or "hypnotic" doses. - To establish remifentanil dosing regimens by studying the concentration of remifentanil at which neuroimaging (neuronal activation-deactivation in MRF) is inhibited. - To validate the mathematical models in relation to the plasma and brain concentrations of propofol and remifentanil. - To validate the value of clinical signs to predict whether a subject feels the painful stimulus received.;Primary end point(s): Functional Magnetic Resonance Imaging (MRI): MRI volumes with "echo planar imaging" (EPI) sequences will be acquired, the contrast of which detects changes in concentration of oxygenated and oxygenated hemoglobin in gray matter (Blood Oxygen Level Dependent, BOLD) and from there infer its metabolic dynamics and therefore also of neuronal activity.;Timepoint(s) of evaluation of this end point: 20 mins during treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Demographics: Age, sex, weight, height, dominant cerebral hemisphere, usual medication. Categorical clinical responses: - Abolition of response to the verbal order "open your eyes" (AOV). - Abolition of the eye movement reflex (ARMO). - Abolition of the eyelid reflex (ARP). - Recovery of all these answers. Electroencephalographic data (EEG): - Two-channel unprocessed EEG recording. - Parameters derived from EEG: continuous values ??of hypnosis index (qCON) and analgesia index (qNOX) (Monitor qCON, (Quantium Medical, Spain) Electrodes distributed according to the international system (SI) 10/20, with the following positioning will be used: In front position, 3 electrodes (Positive in Fp, Negative in F7 / F8 and Reference in Fp1 / Fp2). In the parietal-temporal position, 3 electrodes (Positive in T6, Negative in T5 and Reference in Right Neck). The impedance will be less than 5 kOhm. The material used will be RM-compatible: the EEG collection electrodes will be AMBU WhiteSensor 4440M electrodes. The graphite cable (RM-compatible) that transmits information from the electrodes to the monitor, must be 3 meters long, to ensure that the monitor can work outside the area of ??influence of the magnet and no longer, to avoid loss Of signal strength. Adequate EEG channels will be assessed to obtain maximum information with minimal interference with MRI. Map of cortical connectivity ("connectome"): At the end of the RMf session, a magnetic resonance diffusion image (DWI) of 64 gradients will be performed, from which a cortical tractography using spherical deconvolution will be calculated. The data obtained from tractography will be fused with those of the MRI to obtain a map of cortical connectivity, in which the degree of correlation between different brain regions during anesthesia will be analyzed to create a computational model of the anteriorization process. Other secondary variables: - Start and end of administration of propofol. - Start and en | — |
Countries
Spain
Contacts
Public ContactServicio de Anestesia
Hospital del Mar
Outcome results
None listed