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| Name | Class |
|---|---|
| Klinikum rechts der Isar Technische Universität München | UNKNOWN |
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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).
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:
Participants
Exclusion criteria:
Withdrawal criteria:
Patients presenting with any adverse event during induction (excitation, hypotension, bradycardia <40 x min, nausea).
Subsequent refusal to participate in the study
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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)
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postopertive pain | Using the Visual Analog Scale VAS | in Recovery room evolution |
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Inclusion Criteria:
Exclusion Criteria:
Withdrawal criteria:
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Patients over 70 years, programmed to elective surgery longer than 60 min
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlos Fernandez Vega | Contact | 56632281784 | comiteeticasecretaria@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Pablo Sepulveda V., Dr. Med | iversidad Austral, Sevicio de salud Valdivia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Base San Jose | Recruiting | Osorno | Los Lagos Region | Chile |
Publishing in a peer-review journal
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