Synchronous Effect of Anesthetics on fMRI, EEG and Clinical Responses
|ClinicalTrials.gov Identifier: NCT03928366|
Recruitment Status : Completed
First Posted : April 26, 2019
Last Update Posted : May 6, 2019
Background: The mechanisms of action of intravenous anesthetics are unclear and the current monitors have limitations.
This signifies difficulties when assessing the correct dosage due to the considerable inter-individual variability of the patients, particularly in the elderly or seriously ill. It is necessary to customize the administration of anesthetics as underdosage can lead to the patient awareness during aggressive procedures, and over-dosage can cause serious complications and even augment mortality.
Objective: To design a new monitoring system of the levels of consciousness and analgesia in anesthetized subjects which is more accurate than those currently employed. It will be based on the synchronic changes of functional magnetic resonance (fMR) and electroencephalograph (EEG) readings, and clinical responses.
Methodology: Thirty healthy volunteers will be given propofol and remifentanil in different combinations, and painful stimuli will be also applied. The principal variable will be fMR images obtained by echo-planar imaging sequences. Real time will be correlated with cortical connectivity maps (connectome), EEG parameters (qCON, qNOX), clinical responses, and concentrations of anesthetics measured by pharmacokinetic and pharmacodynamic models (TCI).
|Condition or disease||Intervention/treatment||Phase|
|Sedative Overdose||Drug: Propofol Drug: Remifentanil||Phase 1 Phase 2|
Develop a system for monitoring the effect of anesthetics on consciousness and pain, based on synchronous changes in functional neuroimaging, EEG and clinical responses.
- Analyze the changes produced in the cortical connectivity map during the induction of anesthesia to understand the process of "advancement".
- Know more accurately the neuronal circuits involved in propofol-induced sleep.
- Study if the application of a known painful stimulus modifies in any way (clinical, EEG or by RMf) the LOC that has just been reached.
- Establish propofol dosing guidelines adjusted to each patient, studying if they reach the LOC at "sedative" or "hypnotic" doses.
- Establish remifentanil dosing guidelines, adjusted to each patient, studying the concentration of remifentanil to which the pain response in neuroimaging is inhibited (activation deactivation neuronal in fMRI).
- Validate existing mathematical models in relation to plasma and brain concentrations of propofol and remifentanil.
- Validate the value of clinical signs to predict whether a patient feels the painful stimulus received.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Volunteers recieving propofol and then remifentanil.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Synchronous Effect of Anesthetics on fMRI, EEG and Clinical Responses. Development of a More Precise System for Monitoring Anesthetic Effect.|
|Actual Study Start Date :||September 13, 2016|
|Actual Primary Completion Date :||March 2019|
|Actual Study Completion Date :||April 2019|
Experimental: Volunteers recibing propofol and remifentanil
Volunteers receive propofol to the loss of consciousness. Then they receive remifentanil during 12 min (pain stimuli in their finger also)
Other Name: remifentanil
- Time and dose of propofol at loss of conciousness (LOC) [ Time Frame: 10-15 min ]Volunteers stop tightening pneumatic pear. We register time and dose of propofol when the volunteer stops tightening pneumatic pear.
- Register EEG and neuroimage during remifentanil administration. [ Time Frame: 10-15 min ]After LOC, volunteers receive increasing doses of remifentanil and painful stimuli in the nail bed. If apnea, stop infusion remifentanil Volunteers receive increasing doses of remifentanil and painful stimuli in the nail bed. If apnea, stop infusion remifentanil. We registered time, dose, saturation and breathing frecuency in every volunteer.