Actively Recruiting

Phase 4
Age: 18Years - 55Years
FEMALE
ID06418308

Comparison of Intrathecal Epinephrine Versus Dexmedetomidine as Additives in Spinal Anesthesia During Cesarean Section

Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-01-07

62

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of two different drugs, dexmedetomidine and epinephrine, added to a standard spinal anesthesia mixture for cesarean section. The study aims to determine if dexmedetomidine is not worse than epinephrine in providing effective spinal analgesia during cesarean deliveries. This research addresses a gap, as no prior studies have directly compared these two drugs as additives in single-dose spinal analgesia. Participants will receive either 5 mcg of dexmedetomidine or 200 mcg of epinephrine added to the standard spinal mixture, which includes hyperbaric bupivacaine and morphine. This is a randomized, quadruple-blinded study comparing these two active treatments. The spinal anesthesia is given as a single shot during scheduled cesarean sections. During the study, participants will be closely monitored for sensory recovery time, pain levels at various stages of surgery, blood pressure, heart rate, and other vital signs up to 270 minutes after spinal anesthesia. Researchers will also assess opioid use, patient satisfaction, newborn Apgar scores, and any side effects like nausea or shivering. The total study participation includes monitoring during surgery and follow-up assessments up to 24 hours after the procedure.

CONDITIONS

Brief Title

Intrathecal Dexmedetomidine vs Epinephrine

Who Can Participate

Age: 18Years - 55Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant patients
  • Aged 18 to 55 years
  • Scheduled for primary or secondary cesarean section
  • Candidates for single-shot spinal anesthesia
  • Singleton pregnancy
Not Eligible

You will not qualify if you...

  • Refusal of spinal anesthesia
  • Not a candidate for spinal anesthesia due to coagulopathy, elevated intracranial pressure, infection at injection site, or similar conditions
  • Emergency cesarean section
  • Preexisting motor or sensory deficit
  • Suspected pre-eclampsia
  • Receiving combined spinal-epidural anesthesia
  • Body mass index (BMI) greater than 40

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Up to 150 minutes

Participants receive a single-shot spinal anesthesia with either dexmedetomidine or epinephrine added to a standardized spinal medication mixture during cesarean section.

1 in-person treatment visit during surgery

Follow-up

Duration - Up to 24 hours

Participants are monitored for recovery, side effects, and satisfaction after the surgery.

1 post-operative visit on Day 1

Trial Site Locations

Total: 1 location

1

Mount Sinai Hospital

New York, New York, United States, 10029

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Research Team

T

Talia Scott, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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