Research question: Does subcortical drug-based anesthesia allow better recovery of
consciousness (integration of information) than the classic gabaergic drug-based technique in
elderly and fragile brains?
Primary hypothesis: The anesthetic technique based on subcortical anesthesia with
Dexmedetomidine and Remifentanil and minimal gabaergic doses (Propofol) allow fragile and
slower brains a faster recovery of cortical connectivity. This behavior represents part of
the evidence of neural inertia in sleep and anesthesia.
Objectives:
Primary: Evaluation of the normalization of the frontal EEG of patients with mostly
subcortical anesthesia (Dexmedetomidine-Remifentanil.-low Propofol in TCI ) or classic
technique (Remifentanil-Propofol in TCI) versus its preoperative basal control.
Secondary:
To estimate the recovery of the cognitive condition with MoCA test, agitation
scale, and delirium CAM-ICU.
To identify behavioral patterns of the EEG with two different anesthetic techniques
Participants
Target population: Patients scheduled for elective surgery, any sex, non-neurological
procedure lasting more than 60 minutes, who do not meet the exclusion criteria.
Eligibility criteria Inclusion criteria: - ASA I - II - Age: over 70 years old
Exclusion criteria:
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
Randomize patients into two groups of a similar number of individuals. Group 1:
Propofol TCI - Remifentanil anesthesia. TCI Propofol (Schnider PKPD model),
5-minute step-by-step induction. After LOC stay in this calculated effect site
concentration, add Remifentanil TCI PKPD model Minto target 4.5 ng/ml, Rocuronium
intubation dose. EEG Sedline monitoring all the surgery until 1 hour
postoperatively Group 2: Dexmedetomidine 0.8 ug/kg/h during 10 minutes- then
Propofol TCI target 2 ug/ml (Schnidel model) during 3 min and reduce to 0.5 ug/ml,
Remifentanil TCI (PK model Minto), after LOC Rocuronium intubation dose. EEG
Sedline monitoring all the surgery until 1 hour postoperatively 0,5 ug/ml after LOC
Both groups were evaluated with MoCA and CAMICU tests: Pre-operative and
post-operative cognitive assessments will be performed with MoCA test and CAMICU
test, which will be correlated with the EEG characteristics of each group both in
the baseline measurements, intraoperative behavior, and after one hour in the
recovery room
Basal frontal EEG with eyes opened and closed (90 sec each) preoperatively without
any drug effect
To protect the risk of awareness or excess of EEG depression, during surgery, Anesthesia will
be dynamically adjusted to maintain SEF95 remains at minimum values at 8-10 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 (edf data corresponding to raw EEG) and other trends data of
the Sedlie monitor using the proprietary software Masimo Instrument Configuration Tools
In both groups, the Systolic Blood Pressure, Freq. Cardiac, Pulse Oximetry, Capnography, and
Sedline EEG will be monitored throughout the surgical procedure and for at least one hour
postoperatively. No drugs such as ketamine, midazolam, atropine, or other anticholinergics
will be used at any time.
Hemodynamics will be supported with volume, ephedrine, or phenylephrine according to the
criteria of the anesthesiologist.
Unexpected events during the induction: Any anesthetic induction has risks of hemodynamic
instability, arrhythmias, and respiratory apneas. Most of them are easy to handle
anesthesiological based on volume, vasoactive drugs such as ephedrine, and respiratory
assistance.
In this case, a minimum or no incidence of these is expected because healthy patients are
included.
Exceptional situations such as anaphylactic reactions to propofol (very rarely described)
will be cause for suspension of the case study and treated with usual protocols for the case.
During the Surgery, the analgesic requirement will be adjusted with Remifentanil TCI
concentration in the clinical criterium of the anesthetist.
Postoperative analgesia will be multimodal, with or without regional block depending on the
anesthetist's criterium and type of surgery.
Database and data management: SEDLINE data is retrieved online by proprietary software to a
PC. These, together with the manual control data, will be collected in a Microsoft Excel 2011
worksheet and exported to a STATA 10 statistical program template, with which the analysis
will be performed.
A work together with the Basic Data Manager of the Anesthesia Service to safeguard the
information and its confidentiality.