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

NCT05899127 | Unknown Phase 4

• 1 other identifier: hanyi20230118
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Reaction

Outcome Measures

Primary Outcomes (2)

• Stress response index

  It includes blood pressure, heart rate, heart rate variability,IL-6 and TNF-α.

  24 hours

• Serum Norepinephrine

  It may have been involved in the regulation of stress response processes by lidocaine.

  24 hours

Study Arms (2)

Lidocaine

EXPERIMENTAL

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

Drug: Lidocaine

Control group

PLACEBO COMPARATOR

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.

Drug: 0.9%NaCl

Interventions

Lidocaine DRUG

1.5mg/kg induction，1.5 mg/kg/h maintenance

Also known as: Sufentanil,Etomidate,Rocuronium,Propofol,Remifentanil

Lidocaine

0.9%NaCl DRUG

2mg/kg induction，1.5 mg/kg/h maintenance

Also known as: Sufentanil,Etomidate,Rocuronium,Propofol,Remifentanil

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.)
• 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

Sponsors & Collaborators

• Second Hospital of Shanxi Medical University: lead

Study Sites (1)

Second of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

RECRUITING

MeSH Terms

Conditions

Fractures, Stress

Interventions

Lidocaine; Sufentanil; Sodium Chloride

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: June 12, 2023
• Study Start: July 22, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 31, 2024
• Last Updated: January 25, 2024

Record last verified: 2024-01

Locations

CN (1)