Dexmedetomidine vs Epinephrine for Cesarean Section

Overseen By Talia Scott, MD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Coagulopathy, Elevated intracranial pressure, Infection, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

62 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two medications, dexmedetomidine and epinephrine, to determine which provides better pain relief during a cesarean section (C-section). Both drugs are added to the spinal anesthesia mix, a common method for pain control during C-sections. The researchers aim to discover if dexmedetomidine matches or surpasses epinephrine in managing pain without causing additional side effects. This trial targets pregnant patients scheduled for a planned C-section who are suitable candidates for spinal anesthesia. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand its benefits for more patients.

Will I have to stop taking my current medications?

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.

What is the safety track record for these treatments?

Research has shown that both dexmedetomidine and epinephrine are safe for use during cesarean sections, with no major side effects reported. Studies have found that adding dexmedetomidine to spinal anesthesia is well-tolerated by mothers and does not harm babies. It effectively manages pain without significant risks.

Epinephrine is also used safely in cesarean deliveries. It prolongs the anesthesia's effect and reduces the need for pain medication afterward. Additionally, it helps prevent low blood pressure during surgery and is generally effective and safe.

Both treatments have been studied in various settings, confirming their safety and benefits during cesarean sections. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for cesarean sections because they explore new ways to manage anesthesia during surgery. Dexmedetomidine, an investigational treatment, is unique because it has sedative and pain-relief properties that might enhance patient comfort and reduce the need for other medications. On the other hand, epinephrine is already used to prolong the effects of anesthesia, but researchers are examining how its specific combination with spinal medication might optimize outcomes. These treatments could potentially offer more effective and tailored anesthesia options for cesarean sections, improving the experience and safety for both mothers and babies.

What evidence suggests that this trial's treatments could be effective for cesarean section?

This trial will compare the effects of dexmedetomidine and epinephrine as additions to standard spinal anesthesia for cesarean sections. Research has shown that dexmedetomidine reduces shivering during surgery and manages heart and blood pressure responses without affecting the baby's health. Meanwhile, epinephrine effectively prevents low blood pressure during cesarean deliveries and aids in pain relief after surgery. Both treatments enhance the effectiveness of spinal anesthesia, making them promising options for improved pain management during cesarean sections. ^{1 2 3 6 7}

Who Is on the Research Team?

Daniel Katz, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 18-55 scheduled for a cesarean section who can have spinal anesthesia. It's not for those with coagulation issues, infection at the injection site, high brain pressure, emergency C-sections, pre-eclampsia or existing nerve problems.

Inclusion Criteria

I am pregnant, aged 18-55, and scheduled for a cesarean section with spinal anesthesia.

Exclusion Criteria

Suspected pre-eclampsia

I am receiving a combined spinal-epidural for anesthesia.

I have chosen not to have a spinal anesthetic.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive intrathecal dexmedetomidine or epinephrine as adjuvants in single-dose spinal analgesia during cesarean section

1 day

1 visit (in-person)

Immediate Post-Operative Monitoring

Participants are monitored for sensory and motor recovery, blood pressure, heart rate, and other immediate post-operative outcomes

270 minutes

Continuous monitoring during surgery and immediate recovery

Follow-up

Participants are monitored for safety and effectiveness after treatment, including patient satisfaction and opioid use

24 hours

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Dexmedetomidine
• Epinephrine

Trial Overview

The study compares two additives to spinal analgesia: dexmedetomidine and epinephrine. The goal is to see if dexmedetomidine matches or beats epinephrine in improving pain control during and after C-section without more side effects.

How Is the Trial Designed?

Group I: Epinephrine Active Control 2 Interventions

receiving the addition of 200 mcg of epinephrine to the standard spinal medication mixture

Group II: Dexmedetomidine Active Control 2 Interventions

receiving the addition of 5 mcg of dexmedetomidine to the standard spinal medication mixture.

Dexmedetomidine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in United States as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in Canada as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Approved in Japan as Precedex for:

• Sedation in intensive care settings
• Procedural sedation

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

In a study of 36 parturient women with severe preeclampsia, dexmedetomidine significantly reduced cardiac output, heart rate, and blood pressure compared to a saline control, indicating its hemodynamic effects post-cesarean section.

Dexmedetomidine appears to lower heart rate and blood pressure without compromising myocardial contractility or stroke volume, suggesting it can be safely used to manage hemodynamic stability in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Dexmedetomidine on Cardiac Output among Parturient with Severe Preeclampsia after Cesarean Section. Lv, Y., Zhou, Y., Qiao, Y., et al.[2023]

In a study of 580 women undergoing cesarean sections, the addition of dexmedetomidine to standard anesthesia significantly improved the speed and duration of sensory block compared to control groups, indicating enhanced anesthetic efficacy.

Patients receiving dexmedetomidine experienced lower rates of postoperative pain, nausea, vomiting, chills, and fever, suggesting that it not only improves anesthesia but also enhances safety during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Anesthetic Effect and Safety of Dexmedetomidine in Cesarean Section: A Meta-Analysis. Pang, G., Zhu, Y., Zhou, Y., et al.[2023]

Dexmedetomidine is commonly used as a safe sedative during surgeries, but there are rare cases where it can lead to serious complications, such as cardiac arrest.

In this report, a 76-year-old woman experienced cardiac arrest during a pacemaker lead extraction procedure while being treated with dexmedetomidine, highlighting the need for careful monitoring in older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine related cardiac arrest in a patient with permanent pacemaker; a cautionary tale. Shah, AN., Koneru, J., Nicoara, A., et al.[2013]

In a study of 68 pregnant women undergoing elective cesarean delivery, preoperative administration of dexmedetomidine at doses of 0.4 and 0.6 μg/kg/h significantly reduced maternal heart rate, blood pressure, and cortisol levels compared to a placebo, indicating its effectiveness in managing stress responses during surgery.

Importantly, the use of dexmedetomidine did not negatively impact neonatal outcomes, as Apgar scores and other measures of newborn health remained similar across all groups, suggesting it is a safe option for mothers and their babies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of dexmedetomidine in suppressing cardiovascular and hormonal responses to general anaesthesia for caesarean delivery: a dose-response study. El-Tahan, MR., Mowafi, HA., Al Sheikh, IH., et al.[2022]

In a study of 107 parturients undergoing cesarean delivery under neuraxial anesthesia, intravenous dexmedetomidine provided similar effectiveness in preventing conversion to general anesthesia compared to standard adjunct medications like fentanyl and midazolam.

While dexmedetomidine was associated with a statistically significant increase in bradycardia (15% vs. 2% in the standard group), there was no difference in hypotension rates between the two groups, indicating a safety concern that should be monitored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous Dexmedetomidine as an Adjunct to Neuraxial Anesthesia in Cesarean Delivery: A Retrospective Chart Review. Davis, PR., Sviggum, HP., Delaney, DJ., et al.[2022]

Dexmedetomidine, a selective α-2 agonist, has shown promise in improving outcomes for obstetric patients undergoing emergency cesarean deliveries, particularly in cases with complications like pre-eclampsia and postpartum hemorrhage.

In this specific case, dexmedetomidine effectively controlled blood pressure and reduced uterine bleeding during the cesarean section, highlighting its potential benefits in critical situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postpartum hemorrhage and pregnancy induced hypertension during emergency lower segment cesarean section: dexmedetomidine to our rescue]. Hariharan, U.[2019]

In a study of 120 patients undergoing elective cesarean sections, dexmedetomidine provided better neonatal outcomes, with higher Apgar scores and lower postoperative pain scores compared to remifentanil.

Remifentanil showed better hemodynamic stability during surgery, but it was associated with a higher percentage of neonates scoring less than 7 on the Apgar scale at 1 minute after delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of dexmedetomidine versus remifentanil on mothers and neonates during cesarean section under general anesthesia. Yu, Z., Zhang, P., Wang, H., et al.[2021]

In a study involving 91 pediatric patients, dexmedetomidine was found to be a well-tolerated alternative sedative for non-intubated moderate or deep sedation, with a low incidence of serious adverse events.

While respiratory depression and hypotension were the most common treatment-emergent adverse events, they were manageable and consistent with dexmedetomidine's known safety profile, indicating its potential for safe use in children during elective procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation. Jooste, EH., Hammer, GB., Reyes, CR., et al.[2020]

Intrathecal dexmedetomidine (DEX) is safe for the fetus during cesarean sections, showing no significant differences in neonatal outcomes compared to placebo, based on a meta-analysis of 10 randomized controlled trials.

In addition to being safe, intrathecal DEX significantly prolongs the postoperative pain-free period and reduces shivering in mothers without increasing adverse effects associated with spinal anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal and Maternal Responses to Dexmedetomidine Intrathecal Application During Cesarean Section: A Meta-Analysis. Sun, S., Wang, J., Wang, J., et al.[2020]

Citations

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