Clinical trial NCT06418308: Intrathecal Dexmedetomidine Vs Epinephrine
Official title: Comparison of Intrathecal Epinephrine Versus Dexmedetomidine As Adjuvants in Cesarean Section
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cesarean Section
Anesthesia, Spinal
Keywords: Cesarean Section
Spinal Anesthesia
Intrathecal adjuncts
Dexmedetomidine
Epinephrine
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to either receiving the addition of epinephrine or dexmedetomidine to the standard spinal medication mixture of 10.25 mg hyperbaric bupivacaine, and 0.125 mg morphine.
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: Time required for sensory recovery
timeFrame: 270 minutes
Secondary outcomes:
measure: Time to Bromage Score 1
timeFrame: 270 minutes
measure: Blood Pressure
timeFrame: 30 minutes
measure: Phenylephrine Infusion Rate
timeFrame: 2 to 30 minutes
measure: Total Phenylephrine Infusion
timeFrame: during surgery which can go up to 150 minutes
measure: Number of Phenylephrine Boluses
timeFrame: during surgery which can go up to 150 minutes
measure: Number of Ephedrine Boluses
timeFrame: during surgery which can go up to 150 minutes
measure: Number of Nausea episodes
timeFrame: 60 minutes
measure: Number of Vomiting episodes
timeFrame: 60 minutes
measure: Number of Shivering episodes
timeFrame: 60 minutes
measure: Number of Pruritus episodes
timeFrame: 60 minutes
measure: Pain Score at Skin Incision
timeFrame: within the surgery, which can go up to 150 minutes
measure: Pain Score at Uterine Incision
timeFrame: within the surgery, which can go up to 150 minutes
measure: Pain Score at Uterine Exteriorization
timeFrame: within the surgery, which can go up to 150 minutes
measure: Pain Score at Uterine Closure
timeFrame: within the surgery, which can go up to 150 minutes
measure: Pain Score at Gutter Cleaning
timeFrame: within the surgery, which can go up to 150 minutes
measure: Pain Score at Procedure Finish
timeFrame: at procedure finish, which can go up to 150 minutes
measure: Additional IV Medication
timeFrame: during surgery which can go up to 150 minutes
measure: Number of participants who require Conversion to General Anesthesia
timeFrame: during surgery which can go up to 150 minutes
measure: Heart Rate
timeFrame: total of 30 minutes from the time of spinal placement.
measure: Oxygen Saturation
timeFrame: total of 30 minutes from the time of spinal placement.
measure: Apgar Scores
timeFrame: 1 minute and 5 minutes
measure: Number of NICU admission
timeFrame: Day 1
measure: Patient Satisfaction Score
timeFrame: Post-Op Day 1
measure: Time to First opioid
timeFrame: 24 hours
measure: Total Opioid Dose
timeFrame: 24 hours
measure: Time to sensory block
timeFrame: 20 minutes
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Daniel Katz, MD
role: PRINCIPAL_INVESTIGATOR
References: