Dexmedetomidine or Clonidine for C-Section Anesthesia

Overseen By Richard M Smiley, MD, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Columbia University

Must not be taking: Opioids

Disqualifiers: Cardiovascular, Psychiatric, Respiratory, others

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: 1

Duration: During cesarean surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will examine whether addition of dexmedetomidine or clonidine (two alpha-2 adrenergic agonists) will improve the comfort of patients during spinal anesthesia for cesarean delivery. When added to standard spinal anesthesia consisting of bupivacaine (a local anesthetic) and fentanyl and morphine (two opioids), these medications may decrease some of the pulling/tugging/pressure sensations that patients sometimes feel during cesarean delivery, may prolong the anesthetic time, and may decrease postoperative pain.

Who Is on the Research Team?

Ruth Landau, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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

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

How Is the Trial Designed?

Group I: Dexmedetomidine Experimental Treatment 1 Intervention

Participants will receive 4 mcg dexmedetomidine in addition to the standard spinal anesthetics (12 mg bupivacaine, 15 mcg fentanyl, 150 mcg morphine).

Group II: Clonidine Experimental Treatment 1 Intervention

Participants will receive 30 mcg clonidine in addition to the standard spinal anesthetics (12 mg bupivacaine, 15 mcg fentanyl, 150 mcg morphine).

Group III: Control Active Control 1 Intervention

Participants will receive standard spinal anesthetics (12 mg bupivacaine, 15 mcg fentanyl, 150 mcg morphine).

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+