Effect of Intravenous Lidocaine on Serum miRNA-135a in Patients Undergoing Non-cardiac Surgery

Not Applicable

• Conditions: Organ Protection
• Interventions: Drug: Normal saline; Drug: Lidocaine

• Registration Number: NCT05503043
• Lead Sponsor: General Hospital of Ningxia Medical University

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.

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2022-08-13
• Last Update Submitted: 2022-08-13
• Study First Posted: 2022-08-16
• Last Update Posted: 2022-08-16
• Study Start: 2022-09-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	MMSE was performed