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

90 Participants Needed

Trial Summary

What is the purpose of this trial?

Several studies have shown that adding dexmedetomidine or epinephrine to single-dose spinal analgesia preparations improves the length and/or speed of onset of the sensory block and post-operative pain management without increased negative side effects. To date, however, no study has compared adjunctive intrathecal dexmedetomidine to adjunctive intrathecal epinephrine in single-dose spinal analgesia. The purpose of this study is to determine if adjunctive intrathecal dexmedetomidine is non-inferior to adjunctive intrathecal epinephrine in providing better single-dose spinal analgesia during cesarean section.

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 data supports the effectiveness of the drug Dexmedetomidine for cesarean section?

Research shows that Dexmedetomidine can help manage blood pressure and reduce bleeding during cesarean sections, especially in patients with high blood pressure and heavy bleeding. It also helps reduce stress responses during surgery without harming the baby. ^{1 2 3 4 5}

Is dexmedetomidine safe for use in cesarean sections and other procedures?

Dexmedetomidine is generally considered safe for use in cesarean sections and other procedures, with studies showing it is well-tolerated in both adults and children. However, there have been rare cases of serious side effects, such as cardiac arrest, especially in patients with pre-existing conditions like a pacemaker. ^{1 3 6 7 8}

How is the drug combination of Dexmedetomidine and Epinephrine unique for cesarean section?

Dexmedetomidine is unique because it can reduce stress responses and lower blood pressure during cesarean sections, which is particularly beneficial for patients with high blood pressure or excessive bleeding. This makes it different from other drugs that might not address these specific issues as effectively. ^{1 3 4 5 9}

Research Team

Daniel Katz, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Anesthetic Effect and Safety of Dexmedetomidine in Cesarean Section: A Meta-Analysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Intravenous Dexmedetomidine as an Adjunct to Neuraxial Anesthesia in Cesarean Delivery: A Retrospective Chart Review. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of dexmedetomidine in suppressing cardiovascular and hormonal responses to general anaesthesia for caesarean delivery: a dose-response study. [2022]

4. Brazil pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Effect of Dexmedetomidine on Cardiac Output among Parturient with Severe Preeclampsia after Cesarean Section. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Dexmedetomidine related cardiac arrest in a patient with permanent pacemaker; a cautionary tale. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Fetal and Maternal Responses to Dexmedetomidine Intrathecal Application During Cesarean Section: A Meta-Analysis. [2020]

9. Czech Republic pubmed.ncbi.nlm.nih.gov

Effects of dexmedetomidine versus remifentanil on mothers and neonates during cesarean section under general anesthesia. [2021]