RecruitingPhase 4NCT06418308

Intrathecal Dexmedetomidine vs Epinephrine

Comparison of Intrathecal Epinephrine Versus Dexmedetomidine as Adjuvants in Cesarean Section


Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

62 participants

Start Date

Sep 17, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 55 Years

Inclusion Criteria4

  • Pregnant patients
  • aged 18-55 years
  • presenting for scheduled primary or secondary cesarean section
  • candidates for single shot spinal anesthesia singleton pregnancy

Exclusion Criteria7

  • patient refusal of spinal anesthetic
  • if patient is not a candidate for spinal anesthesia due to history of coagulopathy, elevated intracranial pressure, infection at site of injection, etc.
  • emergency cesarean section
  • preexisting motor or sensory deficit
  • suspected pre-eclampsia
  • patient receiving combined spinal-epidural as anesthetic technique
  • BMI \> 40

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Interventions

DRUGDexmedetomidine

5 mcg of dexmedetomidine

DRUGEpinephrine

200 mcg of epinephrine

DRUGStandardized Spinal Mixture

Standardized spinal mixture of 10.25 mg hyperbaric bupivacaine, and 0.125 mg morphine.


Locations(1)

Mount Sinai Hospital

New York, New York, United States

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NCT06418308


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