Clinical trial NCT05503043: Effect of Intravenous Lidocaine on Serum miRNA-135a in Patients Undergoing Non-cardiac Surgery
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Organ Protection
Keywords: lidocaine
postoperative cognitive dysfunction
miRNA-135a
Rock2
Add1
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective non-cardiac surgery under general anesthesia
* ASA physical status II-III
* Aged ≥65 years

Exclusion Criteria:

* 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

Primary outcomes:
measure: Changes from Baseline miRNA-135A at the end of surgery immediately and 1, 3days after surgery
timeFrame: at preoperation, at the end of surgery immediately, 1day and 3day after surgery
measure: Changes from Baseline Rock2 at the end of surgery immediately and 1, 3days after surgery
timeFrame: at preoperation, at the end of surgery immediately, 1day and 3day after surgery
measure: Changes from Baseline Add1 at the end of surgery immediately and 1, 3days after surgery
timeFrame: at preoperation, at the end of surgery immediately, 1day and 3day after surgery
Secondary outcomes:
measure: Changes from Baseline mini-mental state examination (MMSE) at the end of surgery immediately and 1, 3days after surgery
timeFrame: at preoperation,1day and 3day after surgery
Other outcomes:
measure: Postoperative cognitive dysfunction (POCD)
timeFrame: at preoperation,1day and 3day after surgery
Locations:
Study officials:
affiliation: General Hospital of Ningxia Medical University
name: Li Zhao
role: PRINCIPAL_INVESTIGATOR
References: