Stress ReactionPhase 4NCT05899127
Relationship Between Lidocaine and Serum Orphanin FQ (N/OFQ)
A Phase 4 study testing Lidocaine and 0.9%NaCl in people with Stress Reaction, run by Second Hospital of Shanxi Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Stress Reaction
- What is being tested?
- Lidocaine and 0.9%NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2023to 31 Jul 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I-II
- Patients undergoing elective abdominal surgery with anesthesia duration less than 1-2h
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second of Shanxi Medical University
Taiyuan, Shanxi, 030001
zheng Guo, 13753171979, 13753171979@163.com
About this study
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)
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.
Read the 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.
- Conditions
- Stress Reaction
- Being tested
- Lidocaine, 0.9%NaCl
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Sufentanil,Etomidate,Rocuronium,Propofol,Remifentanil
1.5mg/kg induction，1.5 mg/kg/h maintenance
0.9%NaClDrug
Also called Sufentanil,Etomidate,Rocuronium,Propofol,Remifentanil
2mg/kg induction，1.5 mg/kg/h maintenance
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 0.9%NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress response index
It includes blood pressure, heart rate, heart rate variability,IL-6 and TNF-α.
Measured: 24 hours
Serum Norepinephrine
It may have been involved in the regulation of stress response processes by lidocaine.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start22 Jul 2023
- Primary completion30 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Shanxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng Guo, Second Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899127
- Sponsor's protocol ID
- hanyi20230118
- Status last verified
- Jan 2024
- First submitted
- 17 Feb 2023
- Last updated
- 25 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05899127
- Acronym / sponsor ID
- hanyi20230118
- Conditions
- Stress Reaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Second Hospital of Shanxi Medical UniversityUniversity, hospital or other
- Study start
- 22 Jul 2023 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Drug: LidocaineLidocaine will be injected intravenously at 1.5mg/kg during anesthesia induction and intravenously pumped at 1.5mg/kg/h during anesthesia induction. |
| Control group | Placebo comparator | Drug: 0.9%NaClNormal 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA I-II
- Patients undergoing elective abdominal surgery with anesthesia duration less than 1-2h
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineAlso: Sufentanil,Etomidate,Rocuronium,Propofol,Remifentanil1.5mg/kg induction，1.5 mg/kg/h maintenance | Drug | Lidocaine |
| 0.9%NaClAlso: Sufentanil,Etomidate,Rocuronium,Propofol,Remifentanil2mg/kg induction，1.5 mg/kg/h maintenance | Drug | Control group |
Primary outcome
Stress response index
Time frame: 24 hours
It includes blood pressure, heart rate, heart rate variability,IL-6 and TNF-α.
Serum Norepinephrine
Time frame: 24 hours
It may have been involved in the regulation of stress response processes by lidocaine.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
Related trials for Stress Reaction
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Active, not recruitingObservational study
The Developmental Origins of Suicide Mortality
Suicide Mortality
RecruitingPhase 3
Examining 3,4-methylenedioxymethamphetamine (MDMA) Effects on Psychological, Relational and Hyperarousal-Related Neural Reactivity Mechanisms in Veterans With PTSD and Moral Injury
PTSD, Post Traumatic Stress Disorder, Moral Injury
Not yet recruiting
Acute Effect of Aerobic Exercise on Cardiovascular Reactivity During a Mental Stress Test in Teachers
Behavior
RecruitingPhase 1
Acute Effects of Cannabis on Cognition and Affect
Cannabis Use
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine and 0.9%NaCl in people with Stress Reaction, run by Second Hospital of Shanxi Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress response index (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.