Intrathecal Dexmedetomidine Vs Epinephrine

Mount Sinai Health System

Status and phase: Enrolling; Phase 4

Conditions: Cesarean Section; Anesthesia, Spinal

Treatments: Drug: Standardized Spinal Mixture; Drug: Dexmedetomidine; Drug: Epinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT06418308

STUDY-23-01613

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups

Dexmedetomidine

Active Comparator group

Description:

receiving the addition of 5 mcg of dexmedetomidine to the standard spinal medication mixture.

Treatment:

Drug: Dexmedetomidine

Drug: Standardized Spinal Mixture

Epinephrine

Active Comparator group

Description:

receiving the addition of 200 mcg of epinephrine to the standard spinal medication mixture

Treatment:

Drug: Epinephrine

Drug: Standardized Spinal Mixture