Intrathecal Dexmedetomidine vs Epinephrine
NCT06418308 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 62
Last updated 2026-01-07
Summary
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.
Conditions
- Cesarean Section
- Anesthesia, Spinal
Interventions
- DRUG
-
Dexmedetomidine
5 mcg of dexmedetomidine
- DRUG
-
200 mcg of epinephrine
- DRUG
-
Standardized Spinal Mixture
Standardized spinal mixture of 10.25 mg hyperbaric bupivacaine, and 0.125 mg morphine.
Sponsors & Collaborators
-
Icahn School of Medicine at Mount Sinai
lead OTHER
Principal Investigators
-
Daniel Katz, MD · Icahn School of Medicine at Mount Sinai
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-17
- Primary Completion
- 2026-03-31
- Completion
- 2026-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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