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临床试验/NCT05502705
NCT05502705尚未招募不适用

Effects of Intravenous Lidocaine on Serum BDNF, NGF, miRNA-206 and miRNA-98 in Elderly Patients Undergoing Abdominal Surgery Under General Anesthesia

General Hospital of Ningxia Medical University0 个研究点目标入组 50 人开始时间: 2022年9月1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
尚未招募
发起方
入组人数
50
主要终点
Changes from Baseline BDNF at 1, 3 days after surgery

研究概览

简要总结

The purpose of this study is to investigate the efficacy of intravenous lidocaine on BDNF, NGF, miRNA-206 and miRNA-98 in serum in elderly patients undergoing abdominal surgery under general anesthesia.

详细描述

Postoperative cognitive dysfunction (POCD) is a major complication following surgeries and anesthesia, especially in elderly individuals. Lidocaine, an inexpensive, widely available, and relatively safe compound, is a local anesthetic that readily crosses the blood-brain barrier. Intravenous lidocaine can reduce the incidence of POCD. However, the mechanism is still unclear.

Brain-derived neurotrophic factor (BDNF) and nerve growth factor (NGF), which are regulated by miRNA-206 and miRNA-98 respectively, play a key role in learning, memory, and cognition. Previous studies have shown that the levels of BDNF and NGF can be improved by lidocaine.

The objective of this study is to investigate the efficacy of intravenous lidocaine on the incidence of early POCD, and the levels of BDNF, NGF, miRNA-206 and miRNA-98 in elderly patients undergoing abdominal surgery under general anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
65 Years 至 80 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients were scheduled by following abdominal surgery under general anesthesia
  • Aged 65 - 80 years
  • ASA physical status Ⅱ-Ⅲ

排除标准

  • Severe heart, pulmonary, hepatic and renal insufficiency
  • History of neurological diseases (including Alzheimer's disease and stroke history)
  • Psychological disorder, and drug or alcohol abuse
  • History of anesthesia and surgery
  • psychiatric illness
  • Unwillingness to comply with the protocol or procedures
  • Allergic to lidocaine
  • Mini-Mental State Examination (MMSE) score<23 before surgery

研究组 & 干预措施

Lidocaine

Experimental

Intravenous bolus of 1.5 mg/kg of lidocaine followed by a continuous infusion of 3.0 mg/kg for the first hour, 1.5 mg/kg for the second hour, 0.7 mg/kg until the end of the surgery.

干预措施: Lidocaine (Drug)

Normal saline

Placebo Comparator

Normal saline administered as a bolus and an infusion with identical volume and rate changes as the treatment group.

干预措施: Normal saline (NS) (Other)

结局指标

主要结局

Changes from Baseline BDNF at 1, 3 days after surgery

时间窗: at preoperation,1 and 3 days postoperation

Venous blood samples were sampled before anaesthesia induction and 1, 3 days after surgery for the BDNF by using Enzyme-linked immunosorbent assay.

Changes from Baseline NGF at 1, 3 days after surgery

时间窗: at preoperation,1 and 3 days postoperation

Venous blood samples were sampled before anaesthesia induction and 1, 3 days after surgery for the NGF by using Enzyme-linked immunosorbent assay.

Changes from Baseline miRNA-206 at 1, 3 days after surgery

时间窗: at preoperation,1 and 3 days postoperation

Venous blood samples were sampled before anaesthesia induction and 1, 3 days after surgery for the miRNA-206 by using PCR.

Changes from Baseline miRNA-98 at 1, 3 days after surgery

时间窗: at preoperation,1 and 3 days postoperation

Venous blood samples were sampled before anaesthesia induction and 1, 3 days after surgery for the miRNA-98 by using PCR.

次要结局

  • Changes from Baseline mini-mental state examination (MMSE) at 1, 3 days after surgery(at preoperation,1 and 3 days postoperation)

研究者

发起方
General Hospital of Ningxia Medical University
申办方类型
Other
责任方
Sponsor

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