Dexmedetomidine or Clonidine for C-Section Anesthesia

RM
Overseen ByRichard M Smiley, MD, PhD
Age: 18+
Sex: Female
Trial Phase: Phase 4
Sponsor: Columbia University
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 tests whether adding dexmedetomidine or clonidine to standard spinal anesthesia can make cesarean deliveries more comfortable. These medications might reduce sensations of pulling or pressure during the procedure and could also alleviate pain afterward. Participants will receive either clonidine, dexmedetomidine, or just the standard anesthesia for comparison. Pregnant women planning a C-section with spinal anesthesia, who do not have certain medical conditions, may be suitable candidates. As a Phase 4 trial, this research involves treatments already FDA-approved and proven effective, aiming to understand how they can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using opioids or have a chronic pain syndrome, you would not be eligible to participate.

What is the safety track record for these treatments?

Research shows that both clonidine and dexmedetomidine are generally safe for use in spinal anesthesia during cesarean sections.

For clonidine, studies have found it improves pain relief without increasing the risk of serious side effects such as low blood pressure, itching, or nausea. One study noted that clonidine might cause more drowsiness, but it wasn't linked to other serious issues.

Regarding dexmedetomidine, evidence suggests it is safe for both mothers and babies during cesarean deliveries. Research highlights its ability to reduce pain with fewer side effects compared to traditional opioid medications.

Both treatments have undergone extensive study and are considered safe options to enhance comfort during cesarean deliveries.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using clonidine and dexmedetomidine for C-section anesthesia because these treatments offer potentially enhanced pain management. Clonidine adds to the mix by providing additional sedative and analgesic effects, which may improve patient comfort without increasing opioid use. Meanwhile, dexmedetomidine is known for its ability to provide sedation while keeping patients conscious and cooperative, which is a unique feature compared to other sedatives. These drugs could offer a more tailored anesthesia experience during C-sections, improving overall patient outcomes and reducing reliance on conventional opioids.

What evidence suggests that this trial's treatments could be effective for improving comfort during C-section anesthesia?

This trial will compare the effects of adding clonidine or dexmedetomidine to standard spinal anesthesia for cesarean sections. Research has shown that adding clonidine can enhance pain relief, prolong the anesthesia's duration, and reduce pain. Similarly, using dexmedetomidine as an add-on also reduces pain and extends the anesthesia's effect. Both treatments have shown promising results in making cesarean deliveries more comfortable. Participants in this trial will receive either clonidine or dexmedetomidine in addition to standard spinal anesthetics, or they will receive the standard spinal anesthetics alone.12467

Who Is on the Research Team?

RL

Ruth Landau, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for pregnant women at least 37 weeks along, having a cesarean delivery with spinal anesthesia. Women can't join if they have major heart, lung, or mental health issues, are carrying multiples, have had many prior C-sections, are allergic to study drugs, use opioids regularly, or don't speak English or Spanish.

Inclusion Criteria

I am pregnant and having a C-section with spinal anesthesia.

Exclusion Criteria

I am scheduled to have a vertical skin incision.
I have serious heart, mental health, or lung problems.
Multiple gestation
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive spinal anesthesia with either clonidine, dexmedetomidine, or standard anesthetics during cesarean delivery

During cesarean surgery
1 visit (in-person)

Immediate Postoperative Monitoring

Participants are monitored for side effects and recovery in the post-anesthesia care unit

2-3 hours
Continuous monitoring

Follow-up

Participants are monitored for postoperative pain and recovery using the Obstetric Quality of Recovery Score

48 hours
Multiple assessments (0-6, 6-12, 12-24, 24-48 hours after surgery)

What Are the Treatments Tested in This Trial?

Interventions

  • Clonidine
  • Dexmedetomidine

Trial Overview

The study tests whether adding dexmedetomidine or clonidine to standard spinal anesthesia (bupivacaine plus fentanyl and morphine) during C-section improves comfort and reduces pain after surgery compared to the usual approach.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: DexmedetomidineExperimental Treatment1 Intervention
Group II: ClonidineExperimental Treatment1 Intervention
Group III: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

Citations

The impact of neuraxial clonidine on postoperative analgesia ...

This review demonstrates that neuraxial clonidine enhances postoperative analgesia in women having Caesarean section with neuraxial anaesthesia.

The effect of addition of intrathecal clonidine to hyperbaric ...

They observed that the addition of clonidine (75 μg) to hyperbaric bupivacaine prolongs spinal anesthesia after caesarean section and improves early analgesia, ...

Comparative Study of Different Doses of Clonidine as an...

The main aim of study was to establish safe and effective dose of intrathecal clonidine as adjuvant to levobupivacaine in caesarean section surgeries. T1-4 ...

4.

sigmarepository.org

sigmarepository.org/samford/35/

The impact of Neuraxial Clonidine in the cesarean patient

In doses ranging from 15-100 mcg, clonidine has the potential to prolong the duration of blockade, shorten onset time, potentiate the quality of ...

Intrathecal clonidine as an adjuvant for neuraxial ...

Clonidine is an effective and safe adjuvant to local anaesthetics for spinal anaesthesia for caesarean delivery. This opens the debate as to whether intrathecal ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28823524/

Intrathecal clonidine as an adjuvant for neuraxial ...

Clonidine increased sedation, RR 3.92 (95% CI 1.17 to 13.14), but did not increase the risk of hypotension, pruritus or postoperative nausea and vomiting. Apgar ...

Adding Dexmedetomidine or Clonidine to Spinal ...

The primary outcome of this study is the incidence of self-reported intraoperative discomfort, defined as pain or uncomfortable pressure, ...