Dexmedetomidine + Ketamine for Anesthesia Study

AE
Overseen ByAaron Ellis
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores brain function during different levels of anesthesia using either dexmedetomidine (a sedative) or ketamine (an anesthetic), both common drugs. The researchers aim to identify which brain regions remain active under anesthesia. The trial involves healthy, right-handed individuals who have played racquet sports at least 30 times and have a BMI under 30. Participants will be divided into groups, with each group receiving one of the drugs while undergoing an fMRI scan. This research could enhance anesthesia use in surgeries. As a Phase 2 trial, it focuses on measuring the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to advancements in anesthesia safety and effectiveness.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both dexmedetomidine and ketamine are generally safe, but some considerations are necessary. Studies have found that dexmedetomidine can cause side effects such as changes in blood pressure and heart rate. It is typically safe and effective for calming patients, especially during procedures like MRIs, but caution is advised for those with heart or liver issues.

Ketamine carries a low risk of causing breathing problems at low doses, making it relatively safe. Most studies have found few serious side effects, though ketamine can cause temporary behavioral changes, similar to psychosis, at certain doses.

Both drugs have been used safely in medical settings, but individual reactions can vary. Discuss any concerns with a healthcare provider.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about using Dexmedetomidine and Ketamine for anesthesia because they offer unique benefits compared to traditional options like propofol or opioid-based anesthetics. Dexmedetomidine works by selectively targeting alpha-2 adrenergic receptors, which can lead to sedation without respiratory depression, a common concern with many anesthetics. Ketamine, on the other hand, acts as an NMDA receptor antagonist, providing not just anesthesia but also analgesia and potentially reducing post-operative pain. Together, these treatments could offer a safer and more effective alternative, minimizing side effects and improving recovery times.

What evidence suggests that this trial's treatments could be effective for understanding mental function during anesthesia?

Research has shown that dexmedetomidine, which participants in this trial may receive, aids in sedation and pain relief without impacting breathing. It also enhances recovery after surgery and reduces the need for other anesthetics like propofol. Meanwhile, ketamine, another treatment option in this trial, effectively manages sedation and pain, particularly in short medical procedures. It can reduce the need for strong painkillers and may shorten hospital stays. Both treatments help maintain patient comfort and calmness during procedures.678910

Who Is on the Research Team?

ZH

Zirui Huang, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for healthy adults who do not have any major medical or psychiatric conditions. Participants should not be taking medications that could interfere with anesthesia and must be able to safely undergo MRI scans.

Inclusion Criteria

Body mass index (BMI) less than 30
Participants will have the experience of playing tennis (or other racquet sport) at least 30 times in their lifetime
Healthy study subjects with American Society of Anesthesiologists (ASA)-1 status
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Exclusion Criteria

BMI greater than or equal to 30
Medical contraindication to MRI scanning; unable to undergo MRI scanning because of possible pregnancy or currently breastfeeding
Metallic substances in the body
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sedation and fMRI

Participants undergo sedation with dexmedetomidine or ketamine and are monitored using fMRI to assess covert consciousness

Up to approximately 130 minutes

Follow-up

Participants are monitored for safety and effectiveness after sedation

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Dexmedetomidine
  • Ketamine

Trial Overview

The study tests how two anesthesia drugs, dexmedetomidine (sometimes with propofol) and ketamine, affect brain activity during sedation using fMRI scans. It aims to see if people still show signs of mental function under these drugs.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Ketamine during fMRIExperimental Treatment1 Intervention
Group II: Dexmedetomidine during fMRIExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials
315
Recruited
251,000+

Citations

Effectiveness of dexmedetomidine on patient-centred ...

Compared with placebo or standard of care, intraoperative dexmedetomidine likely results in meaningful improvement in the quality of recovery and chronic pain ...

Efficacy of Dexmedetomidine in Sedation, General, and ...

Controlled randomised trial with 1024 patients demonstrated its effectiveness in decreasing intra-operative anesthetic requirements and particularly propofol ...

Dexmedetomidine - StatPearls - NCBI Bookshelf - NIH

Dexmedetomidine is a useful non-opioid drug used to manage pain and sedation in the ICU and operating room. The drug is effective, but its use ...

Effects of dexmedetomidine in non-operating room anesthesia ...

The most frequent efficacy outcomes reported were sedation level (evaluated in 82 studies) and the most frequent adverse outcomes reported were hemodynamic ...

Dexmedetomidine Dosing Strategies in Sedation and ...

In adults, doses of 0.25– 0.5 μg/kg over 10 minutes appear to provide adequate procedural sedation with acceptable hemodynamic effects; ...

Dexmedetomidine: a real-world safety analysis based on FDA ...

The most prevalent AEs associated with Dexmedetomidine include hypotension, hypertension, and bradycardia (Keating, 2015).

Dexmedetomidine sedation vs. inhaled general anesthesia ...

The sedation failure rate was 42% with dexmedetomidine vs. 0% with general anesthesia (p<0.001). All cases of failure followed the intranasal administration of ...

Dexmedetomidine versus propofol on the sedation of ...

Dexmedetomidine and propofol are both commonly used sedatives in children undergoing MRI examination for their efficacy and safety [5, 17].

Safety of Dexmedetomidine as an Alternative Pediatric ... - PMC

In summary, dexmedetomidine is a very effective drug and can be safely used at therapeutic doses for pediatric sedation during MRI. Additionally ...

Reported Safety and Sedation Outcomes of Intranasal ...

In a recent three-arm RCT, IN DEX achieved a reported sedation success rate of up to 88% compared with oral triclofos and intranasal midazolam, with no ...