Evaluation of the EEG Connectivity Using Predominant Dexmedetomidine as Anesthetic in Fragile Brains

NCT05425069 | Unknown

• 1 other identifier: Universidad Austral
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Elderly brains that present a lower intrinsic cortical activity are very dependent on arousal feeding. In these patients, a strong blockade of afferences generates a synchronic state with a high tendency to sleep. This is done with drugs such as Dexmedetomidine and its indirect effect of inhibiting the amplification of signals and opioids such as remifentanil. Then, by adding a micro-dose of a gabaergic substance to induce loss of consciousness, unconsciousness would be maintained due to the low requirement of a fragile and synchronous brain by a slow continuous injection of an alpha2 agonist. In previous experience, doses of about one-fifth of the usual would be sufficient to maintain unconsciousness (or perhaps disconnected consciousness that could be useful in avoiding excessive depression in slowed integration pathways). These patients also present deficits in the orexinergic response that manifest themselves in greater neuronal inertia and delayed awakening. Gabaergic drugs (propofol and sevoflurane) are especially depressing to orexinergic nuclei. This approach to the elderly brain could have an impact on recovering more easily connectivity of those CNC networks. In elderly patients, one aspect that could control the phenomena of altered connectivity and its impact in developing delirium is the limitation of connection with the environment before the capacity of integration of cortical information has been completely recovered. To analyze frontoparietal connectivity, front frontal coherence, phase lag index, or similar it is necessary to a multichannel EEG (e.g. 10 channels). Otherwise, the frontal EEG from the SEDline monitor device allowed to analyze only spectral characteristics (power, peak frequency, etc.) and correlate them with clinical observations (MoCA).

Conditions

Aging Problems

Keywords

Frailty brain; Dexmedetomidine; Propofol; MoCA test; Frontal EEG

Outcome Measures

Primary Outcomes (2)

• Comparison of both groups in Recovery Cognitive and electroencephalogram EEG Conditions, during and after surgery

  Measuring instruments: Cognitive MoCA test (Montreal Cognitive assessment) pre and one-hour post-operative. Drug consumption to maintain a Spectral Edge Frequency SEF 95 over 10Hz as calculated Propofol effect-site concentration using Schnider PKPD model. Evaluation of basal alpha power preop, at the loss of response time, during de surgery every 20 minutes, and during the first-hour post operatively (in dB) * Neurological milestones: Montreal Cognitive assessment MoCA test pre and one-hour post-op * Anesthetic depth: SEDLINE® spectrogram dynamic during anesthetic all process and one hour after using the Patient state Index, the Spectral edge frequency 95, the alpha band power, the existence of Burst suppression, * Basic monitoring: Electrocardiogram ECG, non-invasive BP, pulse oximetry, and capnography.

  pre, intra and one hour postoperative in recovery room

• Presence of post operative delirium and agitation

  evaluated by sedation-agitation scale SAS every 30 min, and confusion assessment method CAM ICU scale every 30 min

  post operative in recovery room, and late one week

Secondary Outcomes (1)

• Postopertive pain

  in Recovery room evolution

Study Arms (2)

Dexmedetomidine with minimal concentration of propofol (D-P)

Intravenous infusion with Dexmedetomidine for 10 minutes at 0.8 ug/kg/hr and so on, then induction with Propofol TCI Target 2.0 ug/ml (Schnider model) and Remifentanil TCI 4.5 ng/ml. 3 minutes after LOC Propofol will be reduced to 0.5 ug/ml. intubate using Remifentanil 4.5 ng/ml and Rocuronio 0.5 mg/kg. Anesthesia will be dynamically adjusted to maintain SEF95 remains at minimum values at 10 Hz for the rest of the surgery. Sedline will be maintained for up to 60 min post-op. in the recovery room. Data will be retrieved via pen drive stick from SEdline

Drug: Comparison MoCA test and EEG connectivity pre, intra and postoperative between groups P vs D-P

Propofol TCI fine titrated (P)

Basal frontal EEG with eyes opened and closed (90 sec each) The previous bolus of Lidocaine in a 20 mg intravenous dose, TCI Propofol Induction (Schnider Model) is initiated starting 8 mg/kg/h until clinical unconsciousness (LOC loss of response to the call and to moderate stimulus in the shoulder) and then it is passed to TCI to keep the Ce calculated to the LOC. After LOC, we proceed to intubate using Remifentanil 4.5 ng/ml and Rocuronio. Anesthesia will be dynamically adjusted to maintain Sedline SEF 95 value of minimum at 10Hz. Sedline will be maintained for up to 60 min post LOC in the recovery room. Data will be retrieved via pen drive stick.

Drug: Comparison MoCA test and EEG connectivity pre, intra and postoperative between groups P vs D-P

Interventions

Comparison MoCA test and EEG connectivity pre, intra and postoperative between groups P vs D-P DRUG

We compare de impact in EEG, anesthetic condition, and recovery EEG and cognitive clinical characteristic with MoCA test between both groups (propofol vs propofol dexmedetomidine)

Also known as: comparison EEG evolution between study groups

Dexmedetomidine with minimal concentration of propofol (D-P); Propofol TCI fine titrated (P)

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over 70 years, programmed to elective surgery longer than 60 min

You may qualify if:

• surgery over 60 min
• ASA I - II
• Age: over 70 years old

You may not qualify if:

• \- Neurological, or systemic disease that affects the central nervous system in a secondary way
• Abnormal admission neurological physical exam
• Consumption of benzodiazepines, tricyclic antidepressants, sympathomimetics, modafinil, opioid analgesics, histaminergic, antihistamines, cholinergic, anticholinergics, dopaminergic, antidopaminergic, and antihypertensive with alpha-agonist effect in the last 48 hours.
• History of adverse or allergic reactions to Propofol (allergy to soy or any other component of it)
• History of alcohol or drug abuse
• Subjects with "fast sequence induction" indication
• Withdrawal criteria:
• Patients presenting with any adverse event during induction (excitation, hypotension, bradycardia \<40 x min, nausea).
• Subsequent refusal to participate in the study

Sponsors & Collaborators

• Universidad del Desarrollo: lead
• Klinikum rechts der Isar Technische Universität München: collaborator

Study Sites (1)

Hospital Base San Jose

Osorno, Los Lagos Region, Chile

RECRUITING

Study Officials

• Pablo Sepulveda V., Dr. Med

  iversidad Austral, Sevicio de salud Valdivia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Fernandez Vega

CONTACT

56632281784; comiteeticasecretaria@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DrMed Asociated Professor

Study Record Dates

• First Submitted: April 16, 2022
• First Posted: June 21, 2022
• Study Start: January 2, 2022
• Primary Completion: May 16, 2022
• Study Completion: June 30, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Locations

CL (1)