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Dexmedetomidine for Grief

Age: 18+
Sex: Female
Trial Phase: Phase 2 & 3
Sponsor: Stanford University
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 tests dexmedetomidine, a medication that may reduce grief and stress after a second-trimester dilation and evacuation (D&E) procedure. The researchers aim to determine if this medication can lessen the emotional burden and post-traumatic stress symptoms for those undergoing this procedure. Participants will receive either dexmedetomidine or a placebo (a harmless, inactive substance). The trial seeks English or Spanish speakers who are between 16 and 26 weeks pregnant and scheduled for a D&E in an operating room. As a Phase 2 trial, this research measures how well dexmedetomidine works in an initial, smaller group of people, offering participants a chance to contribute to important findings.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that dexmedetomidine is likely to be safe for humans?

Research shows that dexmedetomidine is generally well-tolerated by patients. Studies have found that it can improve recovery after surgery, indicating its effectiveness in stressful situations. Although some reports mention side effects, including serious ones, these are uncommon. For instance, a few studies noted rare serious outcomes like death, often associated with other health issues. Overall, dexmedetomidine is considered safe, having been used successfully in various medical settings, including surgeries and end-of-life care. This suggests it might be a safe option for managing stress and grief during medical procedures.12345

Why do researchers think this study treatment might be promising for grief?

Unlike the standard treatments for grief, which primarily involve therapy and antidepressants, dexmedetomidine offers a unique approach by acting on the central nervous system. Researchers are excited about this treatment because it targets specific brain receptors to potentially provide rapid relief from intense emotional distress. Additionally, dexmedetomidine is administered intravenously, allowing for controlled dosing that can be precisely monitored during treatment. This method may offer a promising alternative for those who don't respond well to conventional therapies.

What evidence suggests that dexmedetomidine might be an effective treatment for grief?

Research has shown that dexmedetomidine might ease symptoms of post-traumatic stress disorder (PTSD) in stressful medical situations. This trial will compare dexmedetomidine with a placebo to evaluate its potential for managing grief after challenging medical procedures. One study found that dexmedetomidine improved recovery and reduced long-term pain after surgery. Additionally, it was associated with lower death rates in patients undergoing heart surgery. These findings suggest that dexmedetomidine could reduce emotional distress and enhance recovery after difficult medical experiences.23567

Are You a Good Fit for This Trial?

This trial is for people who speak English or Spanish, are between 16 and 26 weeks pregnant, and are having a second-trimester dilation and evacuation (D&E) procedure in an operating room.

Inclusion Criteria

* English- or Spanish-fluency
* 16-26 weeks gestation
I had a dilation and evacuation (D&E) procedure done in an operating room.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Perioperative

Participants receive dexmedetomidine or placebo during anesthesia induction for D&E procedure

Immediate (during procedure)
1 visit (in-person)

Post-procedure Monitoring

Participants are monitored in the post-anesthesia care unit (PACU) for recovery

Up to 6 hours
1 visit (in-person)

Follow-up

Participants are assessed for grief, PTSD, and depression symptoms using validated tools

4 weeks
1 visit (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Dexmedetomidine

Trial Overview

The study compares giving dexmedetomidine (a calming medication through IV) versus a placebo during the D&E procedure to see if it helps reduce grief and stress symptoms afterward. Participants are randomly assigned to one of the two groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: DexmedetomidineExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Citations

Perioperative Dexmedetomidine to Reduce Post- ...

Dexmedetomidine has been shown to reduce PTSD symptoms in other high-stress medical and surgical settings. The investigators are undertaking a ...

Exploring the association between dexmedetomidine and all ...

Similarly, 180-day all-cause mortality was significantly lower in patients treated with dexmedetomidine (17.45% and 23.18% among nonusers of ...

Effectiveness of dexmedetomidine on patient-centred ...

Intraoperative dexmedetomidine likely results in meaningful improvement in the quality of recovery and chronic pain after surgery.

Effect of dexmedetomidine on postoperative mortality ... - PMC

In cardiac surgery patients, DEX significantly reduced all-cause mortality (RR 0.39, 95% CI 0.18–0.85; P = 0.02) and in-hospital mortality (RR ...

Descriptive Analysis of Dexmedetomidine's Utility in a ...

Twenty-five adult patients receiving continuous dexmedetomidine for refractory pain at the EoL were identified. These patients were further evaluated for ...

Dexmedetomidine for Grief · Info for Participants

This Phase 2 & 3 medical study run by Stanford University needs participants to evaluate whether Dexmedetomidine will have tolerable side ...

Efficacy and Safety of Dexmedetomidine in the Prevention ...

The primary outcomes measured across studies were the incidence and severity of delirium, as assessed using validated tools such as the ...