What side effects are associated with this type of intervention?

Intravenous anesthetics such as propofol, midazolam, fentanyl, and lidocaine are commonly used for anesthesia. Propofol can cause hypotension, bradycardia, and pain at the injection site. Midazolam may lead to respiratory depression, drowsiness, and amnesia. Fentanyl is associated with respiratory depression, nausea, vomiting, and potential for addiction. Lidocaine, when used intravenously, can cause central nervous system toxicity, including drowsiness, lightheadedness, and in rare cases, cardiac side effects like hypotension and arrhythmias.

What prior FDA approvals exist?

The FDA has approved several intravenous anesthetics for the treatment of anesthesia, including midazolam, propofol, sufentanil, and alfentanil. These drugs are known for their rapid and short-acting properties, making them suitable for continuous infusion techniques. Midazolam is a benzodiazepine used for its sedative and anxiolytic effects, while propofol is a sedative-hypnotic agent favored for its quick onset and recovery profile. Sufentanil and alfentanil are potent opioid analgesics used for their strong pain-relieving properties. These agents are commonly used in various surgical and diagnostic procedures to modulate neural activity and physiological responses to pain.

What other types of research exist?

Promising novel alternatives to intravenous anesthetics for anesthesia patients in 2024 include: 1) Neuraxial anesthesia techniques such as epidural and spinal anesthesia, which have shown reduced perioperative morbidity. 2) Continuous infusion of local anesthetics, which provides consistent analgesia with lower doses. 3) Non-invasive ventilation during neuraxial anesthesia, which offers benefits in managing respiratory function. 4) Advanced closed-loop systems for the delivery of analgesics, sedatives, and paralytics, enhancing safety and efficacy. 5) Multimodal analgesia approaches combining opioid and non-opioid analgesics, nerve blocks, and non-pharmacologic treatments to improve pain control and reduce opioid-related side effects.

← Back to Search

Alpha-2 Adrenergic Agonist

Anesthetics for Pain Management During Surgery (MCA Trial)

Phase 1

Waitlist Available

Led By Keith M Vogt, MD, PhD

Research Sponsored by Keith M. Vogt, MD, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults, age 18-39, who are native English speakers with at least a high school education

Have normal hearing and memory

Must not have

History of neurologic or psychiatric disease, including benign tremor

History of significant pulmonary disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24-hrs post-experiment

Summary

This trial examines how three IV drugs (propofol, dexmedetomidine, fentanyl) affect memory and physiological responses to pain. It targets people experiencing pain to understand how these drugs influence brain activity related to memory and fear, which could help explain anxiety disorders like PTSD. Dexmedetomidine has been shown to improve cognition compared to propofol and may have protective effects against PTSD.

Who is the study for?

This trial is for healthy adults aged 18-39, with normal body weight and hearing, who speak English natively and have at least a high school education. Participants must not be taking psychotropic medications or have a history of certain medical conditions like sleep apnea, diabetes, chronic pain disorders, significant cardiac disease, or metal implants that are incompatible with MRI.

What is being tested?

The study aims to understand how pain affects long-term memory and physiological responses when different intravenous anesthetics (Propofol, Dexmedetomidine) or pain medication (Fentanyl) are used. A placebo group is included for comparison. The effects will be monitored using functional magnetic resonance imaging across five visits without long-term follow-up.

What are the potential side effects?

Possible side effects from the interventions may include typical anesthesia-related reactions such as drowsiness, confusion post-anesthesia, nausea or vomiting. Fentanyl can cause additional issues like respiratory depression if not properly managed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 39 years old, speak English natively, and have finished high school.

Select...

My hearing and memory are normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of neurological or psychiatric conditions, including benign tremor.

Select...

I have a history of serious lung disease.

Select...

I have been diagnosed with obstructive sleep apnea.

Select...

I have a long-term pain condition.

Select...

I have diabetes or nerve damage.

Select...

My BMI is either above 35 or below 18.

Select...

I have significant memory or hearing problems.

Select...

I have a history of serious heart problems, like high blood pressure or irregular heartbeat.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after each experimental item

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after each experimental item

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after each experimental item for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Explicit memory performance

Secondary study objectives

Brain activity in hippocampus and amygdala

Heart rate response

Skin response

Trial Design

3Treatment groups

Experimental Treatment

Group I: PropofolExperimental Treatment3 Interventions

Subjects in this group will receive propofol during the drug portion of the experiment.

Group II: FentanylExperimental Treatment3 Interventions

Subjects in this group will receive fentanyl during the drug portion of the experiment.

Group III: DexmedetomidineExperimental Treatment3 Interventions

Subjects in this group will receive dexmedetomidine during the drug portion of the experiment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Peripheral Nerve Stimulation

2016

Completed Phase 1

~1520

Placebo

1995

Completed Phase 3

~2670

Propofol

2017

Completed Phase 4

~1520

Fentanyl

2019

Completed Phase 4

~1920

Dexmedetomidine

2015

Completed Phase 4

~2050

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Intravenous anesthetics such as propofol and ketamine are commonly used in anesthesia due to their rapid onset and ability to modulate neural activity and physiological responses to pain. Propofol works by enhancing the inhibitory neurotransmitter GABA, leading to sedation and hypnosis, while ketamine acts as an NMDA receptor antagonist, providing both analgesia and dissociative anesthesia. These mechanisms are crucial for minimizing pain and discomfort during surgical procedures, ensuring patient safety, and improving overall outcomes. Etomidate, although less desirable due to its potential to increase airway resistance and cause adrenal dysfunction, also acts on GABA receptors to induce anesthesia. Understanding these mechanisms helps anesthesiologists choose the most appropriate agents to manage pain and maintain stable physiological conditions during surgery.

The Role of Descending Modulation in Manual Therapy and Its Analgesic Implications: A Narrative Review.Management of acute postoperative pain after oral surgery.[Sedation and analgesia in intensive care: physiology and application].