Lidocaine IV for Delirium

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
University of California, San Francisco, San Francisco, CA
Delirium+3 More
Lidocaine IV - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a postoperative intravenous infusion of lidocaine can decrease the risk of postoperative delirium.

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Eligible Conditions

  • Delirium
  • Postoperative Pain
  • Postoperative Delirium (POD)
  • Fusion of Spine (Disease)

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

This trial is evaluating whether Lidocaine IV will improve 1 primary outcome and 22 secondary outcomes in patients with Delirium. Measurement will happen over the course of End of hospitalization, at time of discharge, approximately 1 week..

Baseline and 3 months.
Difference in Functional Outcome Between Treatment Groups Using Oswestry Disability Index (ODI)
Difference in Functional Outcome Between Treatment Groups Using Short Form 36 (SF-36)
Week 1
Difference in Time to Discharge Between Treatment Groups
Day 3
Cognitive Status
Difference in Ability to Participate in Physical Therapy Between Treatment Groups
Difference in Analgesic Satisfaction Scores Between Treatment Groups
Difference in Associative Learning Between Treatment Groups (Cognition)
Difference in Cognitive Functioning Between Treatment Groups
Difference in Verbal Fluency Between Treatment Groups (Cognition)
Incidence of Postoperative Delirium
Severity of Postoperative Delirium
Word List Learning (Cognition)
Hour 24
Postoperative Opioid Use
Hour 4
Difference in Opioid Related Side Effects Between Treatment Groups: Nausea, Vomiting, Constipation-Anti-Emetic Administration
Difference in Opioid Related Side Effects Between Treatment Groups: Nausea, Vomiting, Constipation-Investigator Assessments
Difference in Opioid Related Side Effects Between Treatment Groups: Pruritus-Investigator Assessment
Difference in Opioid Related Side Effects Between Treatment Groups: Respiratory Depression-Naloxone Administration
Difference in Opioid Related Side Effects Between Treatment Groups: Respiratory Depression-Respiratory Rate
Difference in Opioid Related Side Effects Between Treatment Groups: Respiratory Depression-Saturated Pulse Oximetry
Difference in Opioid Related Side Effects Between Treatment Groups: Sedation
Hour 72
Difference in Lidocaine Related Adverse Events Between Treatment Groups
Difference in lidocaine related Adverse Events between treatment groups
Hour 8
Difference in Postoperative Pain Scores Between Treatment Groups

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Intervention-Intravenous Lidocaine Infusion
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 278 total participants across 2 different treatment groups

This trial involves 2 different treatments. Lidocaine IV is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Intervention-Intravenous Lidocaine Infusion
Drug
Will be administered intravenous lidocaine at 1.33mg/kg/hr (adjusted body weight) for 48 hours following major spinal surgery.
Placebo
Drug
Patients will be administered D5 water intravenously at the same infusion rate (ml/hr) as the intervention group for 48 hours after major spinal surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lidocaine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and 3 months.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline and 3 months. for reporting.

Closest Location

University of California, San Francisco - San Francisco, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
We estimate that you will need to stay with us for 3 days or more. show original
and Spanish I am proficient in English and Spanish show original
is a surgical procedure to correct a problem in the spine show original

Patient Q&A Section

Who should consider clinical trials for delirium?

"Patients may be considering randomized clinical trials related to delirium. However, an important consideration is that patients considering such trials are unlikely to have significant outcomes." - Anonymous Online Contributor

Unverified Answer

What are the signs of delirium?

"For determining the specific signs of delirium which are useful for delirium diagnosis, the most important factors are age, history of cancer and past medical history which may be overlooked in the history and physical examinations." - Anonymous Online Contributor

Unverified Answer

What is delirium?

"This is the first study to clarify the association between delirium and patient mortality, following inpatient rehabilitation or discharge. However, it does not provide a definite answer on its usefulness as an indicator of risk in predicting 1-year mortality in hip fracture patients. Recent findings suggest that delirium should be considered as a potential risk marker for poor long-term functional outcomes. Whether the incidence and duration of delirium following hip fracture could be improved by identifying candidates for more aggressive and supportive care remains to be elucidated." - Anonymous Online Contributor

Unverified Answer

How many people get delirium a year in the United States?

"The prevalence of delirium in Americans is estimated at 1.0% a year. The incidence of delirium was higher among female Medicare participants. This research has significant implications for clinicians, administrators, and health care systems' resource allocation." - Anonymous Online Contributor

Unverified Answer

What are common treatments for delirium?

"Delirium has many etiologies, and treatments are tailored for specific patients; common treatments include avoidance of agents that are sedating, and physical therapy and interventions to stabilize the patient's respiratory and cardiovascular systems. The most effective treatment is one that combines these approaches." - Anonymous Online Contributor

Unverified Answer

Can delirium be cured?

"Delirium is commonly experienced after hospital discharge and is associated with lower health-related quality of life. The majority of individuals with delirium who receive cognitive rehabilitation have a clinical remission. It is a common misconception that delirium will be permanent and that treatment, either pharmacological or cognitive, will be necessary indefinitely." - Anonymous Online Contributor

Unverified Answer

What causes delirium?

"There are no clear identifiable causes of delirium. One important factor predisposing individuals to experience delirium is old age. Other associated factors are not well established but include malnutrition, dehydration, substance use, dehydration, low oxygen level, and low cerebral perfusion. The severity and nature of underlying medical conditions can greatly influence the severity and frequency of delirium." - Anonymous Online Contributor

Unverified Answer

Does lidocaine iv improve quality of life for those with delirium?

"Lidocaine is shown to be a safe and effective intervention for delirium in the ED setting. It has a very slight effect on mood and does not impact the quality of life as measured by the SF-36." - Anonymous Online Contributor

Unverified Answer

Is lidocaine iv typically used in combination with any other treatments?

"Results from a recent clinical trial, lidocaine iv plus anesthetic or sedative agent was not associated with an increased rate of adverse effects. Lidocaine alone did not significantly increase hypoalgesia or hypotension." - Anonymous Online Contributor

Unverified Answer

What is the latest research for delirium?

"Most current studies in medicine lack a control group. Therefore, their findings can be only viewed as proof of principle. Even with these shortcomings, the results that are reported in this review can be viewed as having a role in guiding practice." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets delirium?

"Many people in the US are getting delirium at a rate that is three to four times higher than the rate that people would be getting if it was simply a normal part of the healthy aging trajectory. The mean age for someone getting delirium is 92, which is more than 10 years older than the average person. Women who are over 90 years old are 50% more likely to become delirious than women who are 20- to 29-year-old. If a person is over 90 years old, it only takes them about a month to get delirious. This information could help clinicians determine when a person may be susceptible to getting delirium." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in lidocaine iv for therapeutic use?

"Lidocaine is being used as a topical treatment for acute pain in patients of all ages. More recently, it has been utilized for induction, procedural sedation and analgesia in pediatric and non-pediatric patients. Lidocaine usage has also been utilized to help prevent the emergence agitation by a group of patients. The use of lidocaine for sedation has shown success in preventing emergence agitation. The use of lidocaine for painful diagnostic or therapeutic procedures is still being evaluated. Although a few studies have stated that lidocaine is not as irritating or toxic to a child's eyes but it is still used to alleviate severe pain." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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