Synchronous Effect of Anesthetics on fMRI, EEG and Clinical Responses

NCT ID: NCT03928366

Last Updated: 2022-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-13
• Study Completion Date: 2021-06-30

Brief Summary

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, EEG parameters (qCON, qNOX), clinical responses, and concentrations of anesthetics measured by pharmacokinetic and pharmacodynamic models (TCI).

Detailed Description

Main goal:

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 objectives:

• 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.

Conditions

Sedative Overdose

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Volunteers receiving propofol and remifentanil

Volunteers receive propofol to the loss of consciousness. Then they receive remifentanil during 12 min (pain stimuli in their finger also)

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

sedation

Remifentanil

Intervention Type: DRUG

remifentanil

Interventions

Propofol

sedation

Intervention Type: DRUG

Remifentanil

remifentanil

Intervention Type: DRUG

Other Intervention Names

remifentanil

Eligibility Criteria

Inclusion Criteria

• Healthy adult volunteers (ASA 1 physical state) who agree to participate voluntarily in the study, previous information about it by the Principal Investigators (IP).

Exclusion Criteria

• Psychological, psychiatric or neurological disorders. Consumption of drugs. Alterations cutaneous or anatomical cranial. Idiomatic or communication barrier. Allergy to propofol, remifentanil or to some of its excipients. Body mass index (BMI) <18 or> 30 kg / m2. Pregnancy. Airway or ventilation criteria hard. Absence of accompanying adult at the end of the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Parc de Salut Mar

OTHER

Sponsor Role: lead

Responsible Party

Juan Luis Fernández Candil

PhD. Principal investigator.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital del Mar

Barcelona, , Spain

Countries

Spain

References

Borrat X, Ubre M, Risco R, Gambus PL, Pedroso A, Iglesias A, Fernandez-Esparrach G, Gines A, Balust J, Martinez-Palli G. Computerized tests to evaluate recovery of cognitive function after deep sedation with propofol and remifentanil for colonoscopy. J Clin Monit Comput. 2019 Feb;33(1):107-113. doi: 10.1007/s10877-018-0134-3. Epub 2018 Mar 27.

Reference Type: BACKGROUND

PMID: 29589170 (View on PubMed)

Other Identifiers

UNLOCK

Identifier Type: -

Identifier Source: org_study_id