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临床试验/NCT05425069
NCT05425069Unknown不适用

Evaluation of the EEG Connectivity Using Predominantly Dexmedetomidine Anesthesia Versus Traditional TCI Propofol in Fragile Brains

Universidad del Desarrollo1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年1月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
24
试验地点
1
主要终点
Comparison of both groups in Recovery Cognitive and electroencephalogram EEG Conditions, during and after surgery

研究概览

简要总结

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).

详细描述

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:

  1. 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.

  2. Secondary:

  3. To estimate the recovery of the cognitive condition with MoCA test, agitation scale, and delirium CAM-ICU.

  4. To identify behavioral patterns of the EEG with two different anesthetic techniques

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • - 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

研究组 & 干预措施

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

干预措施: Comparison MoCA test and EEG connectivity pre, intra and postoperative between groups P vs D-P (Drug)

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.

干预措施: Comparison MoCA test and EEG connectivity pre, intra and postoperative between groups P vs D-P (Drug)

结局指标

主要结局

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

时间窗: pre, intra and one hour postoperative in recovery room

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.

Presence of post operative delirium and agitation

时间窗: post operative in recovery room, and late one week

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

次要结局

  • Postopertive pain(in Recovery room evolution)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pablo O. Sepulveda

DrMed Asociated Professor

Universidad del Desarrollo

研究点 (1)

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