Recruiting
Phase 4

Dexmedetomidine & Clonidine

Sponsor:

Columbia University

Code:

NCT07567495

Conditions

Cesarean Delivery

Cesarean Delivery; Neuraxial Opioids

Spinal Anesthesia for Cesarean Section

Dexmedetomidine

Clonidine

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Clonidine

Dexmedetomidine

Study Details

Brief summary:

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.

Conditions

Cesarean Delivery

Cesarean Delivery; Neuraxial Opioids

Spinal Anesthesia for Cesarean Section

Dexmedetomidine

Clonidine

Study ID

NCT07567495

Start date

May 14, 2026

Status verified date

Oct, 2026

Completion date

May 15, 2028

Anticipated

Primary completion date

May 14, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Pregnant women undergoing cesarean delivery with spinal anesthesia

Exclusion Criteria:

  • Significant cardiovascular, psychiatric or respiratory disease
  • using opioids or with chronic pain syndrome
  • Multiple gestation
  • BMI >40 kg/m2
  • Quaternary or greater cesarean
  • < 37 weeks gestation
  • Non-English or Spanish speaking
  • planned vertical skin incision
  • planned vertical (classical) uterine incision
  • allergy to clonidine, dexmedetomidine or other study drug

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Clonidine

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

experimental: Dexmedetomidine

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

no intervention: Control

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

Interventions

Clonidine

30 mcg Clonidine will be given by intrathecal administration

Dexmedetomidine

4 mcg Dexmedetomidine will be given by intrathecal administration

Primary outcome measure

  • Incidence of intraoperative discomfort [ Time Frame: during cesarean surgery ]

Central Contacts and Locations

Central contacts

Richard M Smiley, MD, PhD

914-584-9531rms7@cumc.columbia.edu

Locations

Columbia University Irving Medical Center/NewYork Presbyterian Hospital

Recruiting

New York, New York, United States, 10032

Contacts

Richard M Smiley, MD, PhD

914-584-9531rms7@cumc.columbia.edu

Ruth Landau, MD

‭206-605-4527‬rl262@cumc.columbia.edu

Principal Investigator:

Ruth Landau, MD

More Information

Sponsor

Columbia University

Last update posted

Oct 29, 2026

Last verified

Oct, 2026

Keywords

  • cesarean
  • dexmedetomidine
  • clonidine
  • spinal
  • anesthesia
  • Adrenergic alpha-2 Receptor Agonists

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-30. This information was provided to ClinicalTrials.gov by Columbia University on 2026-10-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.