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临床试验/NCT05045170
NCT05045170已完成不适用

The Influence of Propofol and Dexmedetomidine Sedation on Memory Consolidation

I.M. Sechenov First Moscow State Medical University1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2021年5月11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
状态
已完成
入组人数
81
试验地点
1
主要终点
memory consolidation impairment with propofol sedation

研究概览

简要总结

The study of plasticity processes, in particular, memory, is one of the fundamental directions in anesthesiology. To date, there are different views on the impact of sedation and anesthesia on memory. Memory consolidation is one of the most crucial processes that the anesthesiologist is interested in. Memory consolidation is the mechanism of transferring short-term memory to long-term memory. The investigators suppose that propofol or dexmedetomidine sedation disrupts memory consolidation. In addition, the investigators inquired about the impact of sedation on 'working memory'. Therefore, a better understanding of the influence of anesthesia and sedation on basic memory processes will allow the anesthesiologist to balance the choice of the drug and ensure the patient's safety in the intraoperative period.

详细描述

The study is a prospective, randomized, single blind design. Patients undergoing elective trauma surgery (arthroscopy, reconstructive foot surgery) under subarachnoidal anesthesia are enrolled in this study. All patients were randomly divided into three groups depending on the drug type: first - propofol, second - dexmedetomidine, third - control.

The Montreal cognitive assessment test (MoCA - test) is a high validity test. MoCA - test is used to determine cognitive impairments in patients in the pre-operative period. The MoCA test time is approximately 10 minutes. The maximum possible score is 30; 26 points and more are considered normal, 25 or less is evidence of cognitive impairment.

American Society of Anesthesiologists (ASA) physical status classification system is used to assess and communicate a patient's pre-anesthesia medical co-morbidities (ASA I - a normal healthy patient, ASA II - a patient with mild systemic disease, ASA III - a patient with severe systemic disease, ASA IV - a patient with severe systemic disease that is a constant threat to life, ASA V - a moribund patient who is not expected to survive without the operation, ASA VI - a declared brain-dead patient whose organs are being removed for donor purposes.

To determine the level of anxiety and depression in the preoperative period, patients are tested using the Hospital Anxiety and Depression Scale (HADS). Values on the HADS scale<7 points are interpreted as normal, with scores from 8 to 10 as subclinically expressed anxiety and/or depression, and above 10 points-clinically expressed anxiety and/or depression.

In the operating room intravenous (i.v.) peripheral canulla Vasofix Certo (B. Braun, Germany) with a diameter of 18 or 20 Gauge is inserted before the start of regional anesthesia for infusion therapy. Before spinal anesthesia an anesthesiologist inject 0.9% saline infusion (Grotex, Russia) of 6-8 ml/kg.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

Participants were not aware of the drug used for sedation

入排标准

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

入选标准

  • Written informed consent
  • Age ≥ 18 and ≤70 years
  • Elective trauma surgery (arthroscopy, reconstructive foot surgery) under regional anesthesia (spinal anesthesia) with propofol, dexmedetomidine or without sedation
  • Montreal cognitive assessment test ≥ 26
  • Patients with American Society of Anesthesiologists (ASA) I-II
  • Non-inclusion criteria:
  • Not written informed consent to participate in the research and/or perform regional blockade
  • Age˂18 and ˃70 years
  • Allergy to propofol, dexmedetomidine, lidocaine, bupivacaine
  • Pregnancy
  • Epilepsy anamnesis
  • II-III degree atrioventricular block
  • Montreal cognitive assessment test ˂ 26
  • Patients with American Society of Anesthesiologists (ASA) ˃ II
  • Emergency operation
  • The presence of psychiatric disorders
  • Сancer patients with a life expectancy of less than two years
  • Taking anticoagulants, psychotropic drugs

排除标准

  • Patient refuse from further participation
  • Ineffective spinal anesthesia
  • Allergy on anesthesia drugs during perioperative period

研究组 & 干预措施

propofol group

Experimental

patients with American Society of Anesthesiologists (ASA) I-II, Montreal cognitive assessment test≥26, trauma surgery under spinal anesthesia with propofol sedation

干预措施: Influence of propofol sedation on memory consolidation and 'working memory' (Drug)

dexmedetomidine group

Experimental

patients with American Society of Anesthesiologists (ASA) I-II, Montreal cognitive assessment test≥26, trauma surgery under spinal anesthesia with dexmedetomidine sedation

干预措施: Influence of dexmedetomidine sedation on memory consolidation and 'working memory' (Drug)

control group

Placebo Comparator

patients with American Society of Anesthesiologists (ASA) I-II, Montreal cognitive assessment test≥26, trauma surgery under spinal anesthesia without sedation

干预措施: Influence of spinal anesthesia on memory consolidation and 'working memory' (Drug)

结局指标

主要结局

memory consolidation impairment with propofol sedation

时间窗: 24 hours after the end of anesthesia

Memorizing emotionally neutral words before, during and after propofol sedation. Evaluation of recall and recognition of words 24 hours after anesthesia.

memory consolidation impairment with dexmedetomidine sedation

时间窗: 24 hours after the end of anesthesia

: Memorizing emotionally neutral words before, during and after dexmedetomidine sedation. Evaluation of recall and recognition of words 24 hours after anesthesia.

memory consolidation impairment without sedation

时间窗: 24 hours after the end of anesthesia

Memorizing emotionally neutral words before, during and after operation. Evaluation of recall and recognition of words 24 hours after anesthesia.

次要结局

  • 'working memory' impairment without sedation(5 minutes after memorizing emotionally neutral words during operation)
  • 'working memory' impairment with propofol sedation(5 minutes after memorizing emotionally neutral words during propofol sedation)
  • 'working memory' impairment with dexmedetomidine sedation(5 minutes after memorizing emotionally neutral words during dexmedetomidine sedation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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