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

Primary Purpose

Stress Reaction

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Lidocaine
0.9%NaCl
Sponsored by
Second Hospital of Shanxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Reaction

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Second of Shanxi Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine

Control group

Arm Description

Lidocaine will be injected intravenously at 1.5mg/kg during anesthesia induction and intravenously pumped at 1.5mg/kg/h during anesthesia induction.

Normal saline will be injected intravenously at 1.5mg/kg during the induction period and intravenously pumped at 1.5mg/kg/h during the induction period.

Outcomes

Primary Outcome Measures

Stress response index
It includes blood pressure, heart rate, heart rate variability,IL-6 and TNF-α.
Serum Norepinephrine
It may have been involved in the regulation of stress response processes by lidocaine.

Secondary Outcome Measures

Full Information

First Posted
February 17, 2023
Last Updated
June 2, 2023
Sponsor
Second Hospital of Shanxi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05899127
Brief Title
Relationship Between Lidocaine and Serum Orphanin FQ (N/OFQ)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2023 (Anticipated)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Hospital of Shanxi Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Reaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine
Arm Type
Experimental
Arm Description
Lidocaine will be injected intravenously at 1.5mg/kg during anesthesia induction and intravenously pumped at 1.5mg/kg/h during anesthesia induction.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Normal saline will be injected intravenously at 1.5mg/kg during the induction period and intravenously pumped at 1.5mg/kg/h during the induction period.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Sufentanil,Etomidate,Rocuronium,Propofol,Remifentanil
Intervention Description
1.5mg/kg induction,1.5 mg/kg/h maintenance
Intervention Type
Drug
Intervention Name(s)
0.9%NaCl
Other Intervention Name(s)
Sufentanil,Etomidate,Rocuronium,Propofol,Remifentanil
Intervention Description
2mg/kg induction,1.5 mg/kg/h maintenance
Primary Outcome Measure Information:
Title
Stress response index
Description
It includes blood pressure, heart rate, heart rate variability,IL-6 and TNF-α.
Time Frame
24 hours
Title
Serum Norepinephrine
Description
It may have been involved in the regulation of stress response processes by lidocaine.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Second of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zheng Guo
Phone
13753171979
Email
13753171979@163.com

12. IPD Sharing Statement

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

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