Intrathecal Dexmedetomidine vs Epinephrine

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

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06418308
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Anesthesia, Spinal
  • Cesarean Section

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Dexmedetomidine — DRUG
    5 mcg of dexmedetomidine
  • Epinephrine — DRUG
    200 mcg of epinephrine
  • Standardized Spinal Mixture — DRUG
    Standardized spinal mixture of 10.25 mg hyperbaric bupivacaine, and 0.125 mg morphine.

Study Details

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.

Key Dates

Start date
Sep 17, 2024
Status verified
Jan 2026
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
62 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dexmedetomidine
    receiving the addition of 5 mcg of dexmedetomidine to the standard spinal medication mixture.
  • Active Comparator: Epinephrine
    receiving the addition of 200 mcg of epinephrine to the standard spinal medication mixture

Primary Outcome Measure

Time required for sensory recovery [ Time Frame: 270 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai HospitalNew YorkNew York10029
Talia Scott, MD
[email protected]
720-212-7448
Daniel Katz (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
Mount Sinai Hospital· New York, NY

Related Studies