Relationship Between Lidocaine and Serum Orphanin FQ (N/OFQ)

Stress Reaction Clinical Trial

Official title:

Effects of Intravenous Lidocaine Infusion on Stress Response in Patients Undergoing Abdominal Surgery During Perioperative Anesthesia and Its Correlation With Serum Orphanin FQ (N/OFQ)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05899127
• Other study ID #: hanyi20230118
• Status: Recruiting
• Phase: Phase 4
• Start date: July 22, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: January 2024
• Source: Second Hospital of Shanxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The intravenous injection of lidocaine during the perioperative period has been widely used in various types of surgeries. Its clinical effect includes reducing stress response during anesthesia, decreasing pain and opioid consumption, lowering the incidence of postoperative nausea, vomiting, cognitive dysfunction, and reducing the injection pain of propofol. However, despite the positive impact of lidocaine on surgical patients, its mechanism of action remains unclear. Serum N/OFQ is a neurotransmitter that plays an important role in regulating pain and emotion. Therefore, this study aims to explore the effects of perioperative intravenous injection of lidocaine on stress responses in surgical patients, as well as its mechanism of action, and whether Serum N/OFQ participates in this process.

Description:

We hypothesize that intravenous injection of lidocaine during the perioperative period can reduce expression of endogenous opioid peptides, which in turn can decrease secretion of IL-6 and TNF-α, ultimately leading to a reduction in perioperative stress response. This randomized controlled trial will be conducted at the Second Hospital of Shanxi Medical University in China, with the aim of observing changes in stress-related indicators (blood pressure, heart rate, heart rate variability, IL-6, TNF-α, as well as Serum N/OFQ ) between patients undergoing abdominal surgery under total intravenous general anesthesia with and without lidocaine injection. Lidocaine will be administered as a loading dose during anesthesia induction and continued via infusion until the end of anesthesia maintenance, with appropriate depth of anesthesia or BIS readings utilized for monitoring anesthesia depth. Routine monitoring parameters, including blood pressure, heart rate, SpO2, and electrocardiogram, will be recorded and analyzed. Blood samples will be collected 30 minutes before anesthesia induction, 1 minute after tracheal intubation, and at the end of surgery. The use of lidocaine will be evaluated for its impact on perioperative stress response in patients undergoing abdominal surgery, with the relationship to changes in levels of endogenous opioid peptides explored.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 31, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• ASA I-II
• Patients undergoing elective abdominal surgery with anesthesia duration less than 1-2h

Exclusion Criteria:

• It is estimated that patients with difficulty in tracheal intubation (poor head and neck mobility, history of airway surgery, history of OSAHS, nail to chin distance<6cm, Malampati grade 3 and above, mouth opening<2.5cm, obesity (BMI>30kg · m-2), etc.)
• Hypertension patients (clinically diagnosed as hypertension), coronary heart disease patients (with typical symptoms of angina pectoris and exclusion of aortic valve disease, clear history of old myocardial infarction, clear history of acute myocardial infarction)
• Patients with diabetes and central nervous system diseases
• Patients with long-term use of sedatives or antidepressants
• Patients with a history of alcoholism or drug dependence
• Asthma or reactive airway disease
• Shock, severe hypotension, severe arrhythmia and other adverse events occurred during the operation

Related Conditions & MeSH terms

• Fractures, Stress
• Stress Reaction

Intervention

Drug:
• Lidocaine
1.5mg/kg induction,1.5 mg/kg/h maintenance
• 0.9%NaCl
2mg/kg induction,1.5 mg/kg/h maintenance

Locations

Country	Name	City	State
China	Second of Shanxi Medical University	Taiyuan	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Second Hospital of Shanxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stress response index	It includes blood pressure, heart rate, heart rate variability,IL-6 and TNF-a.	24 hours
Primary	Serum Norepinephrine	It may have been involved in the regulation of stress response processes by lidocaine.	24 hours