Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT07567495
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Cesarean Delivery
  • Cesarean Delivery; Neuraxial Opioids
  • Clonidine
  • Dexmedetomidine
  • Postoperative Analgesia
  • Spinal Anesthesia for Cesarean Section

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Clonidine — DRUG
    30 mcg Clonidine will be given by intrathecal administration
  • Dexmedetomidine — DRUG
    4 mcg Dexmedetomidine will be given by intrathecal administration

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

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).

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical Center/NewYork Presbyterian HospitalNew YorkNew York10032
Richard M Smiley, MD, PhD
[email protected]
914-584-9531
Ruth Landau, MD
[email protected]
‭206-605-4527‬
Richard M Smiley, MD, PhD (SUB_INVESTIGATOR)
Ruth Landau, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Columbia University Irving Medical Center/NewYork Presbyterian Hospital· New York, NY

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