跳至主要内容
临床试验/NCT05503043
NCT05503043Unknown不适用

Effects of Intravenous Lidocaine on Serum miRNA-135a and Its Downstream Proteins Rock2 and Add1 in Elderly Patients Undergoing Non-cardiac 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
发起方
入组人数
50
主要终点
Changes from Baseline Add1 at the end of surgery immediately and 1, 3days after surgery

研究概览

简要总结

The purpose of this study is to investigate the effects of intravenous lidocaine on serum miRNA-135a and its downstream proteins Rock2 and Add1 in elderly patients undergoing non-cardiac 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.

Rock2 and Add1, which are regulated by miRNA-135a, play a key role in learning, memory, and cognition.

The objective of this study is to investigate the efficacy of intravenous lidocaine on the incidence of early POCD, and the levels of Rock2, Add1, and miRNA-135a in elderly patients undergoing non-cardiac 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 undergoing elective non-cardiac surgery under general anesthesia
  • ASA physical status II-III
  • Aged ≥65 years

排除标准

  • Serious heart, lung, liver and kidney diseases
  • Central nervous system injury
  • Mental illness and drug dependence
  • On regular use of analgesic/sedative/antidepressant
  • Unable to cooperate
  • Allergy to lidocaine
  • MMSE < 23 points

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 (Drug)

结局指标

主要结局

Changes from Baseline Add1 at the end of surgery immediately and 1, 3days after surgery

时间窗: at preoperation, at the end of surgery immediately, 1day and 3day after surgery

Venous blood was extracted, and the serum Add1 level of patients were detected by PCR and ELISA before surgery, at the end of surgery, 1day and 3day after surgery

Changes from Baseline Rock2 at the end of surgery immediately and 1, 3days after surgery

时间窗: at preoperation, at the end of surgery immediately, 1day and 3day after surgery

Venous blood was extracted, and the serum Rock2 level of patients were detected by PCR and ELISA before surgery, at the end of surgery, 1day and 3day after surgery

Changes from Baseline miRNA-135A at the end of surgery immediately and 1, 3days after surgery

时间窗: at preoperation, at the end of surgery immediately, 1day and 3day after surgery

Venous blood was extracted, and the serum miRNA-135a level of patients were detected by PCR and ELISA before surgery, at the end of surgery, 1day and 3day after surgery

次要结局

  • Changes from Baseline mini-mental state examination (MMSE) at the end of surgery immediately and 1, 3days after surgery(at preoperation,1day and 3day after surgery)

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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