Comparison of Intrathecal Epinephrine Versus Dexmedetomidine as Adjuvants in Cesarean Section
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Time required for sensory recovery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Patients will be assigned a group by picking from a stack of envelopes. The interventional drug which the envelope contains will be assigned by a random number generator. The interventional drug will be drawn up by an anesthesiologist not involved in the patient's care and the syringe given to the anesthesiologist performing the spinal anesthetic.
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Dexmedetomidine
receiving the addition of 5 mcg of dexmedetomidine to the standard spinal medication mixture.
Intervention: Standardized Spinal Mixture (Drug)
Epinephrine
receiving the addition of 200 mcg of epinephrine to the standard spinal medication mixture
Intervention: Standardized Spinal Mixture (Drug)
Dexmedetomidine
receiving the addition of 5 mcg of dexmedetomidine to the standard spinal medication mixture.
Intervention: Dexmedetomidine (Drug)
Epinephrine
receiving the addition of 200 mcg of epinephrine to the standard spinal medication mixture
Intervention: Epinephrine (Drug)
Outcomes
Primary Outcomes
Time required for sensory recovery
Time Frame: 270 minutes
Investigate the efficacy of intrathecal epinephrine versus dexmedetomidine as adjuvant agents in cesarean section. Once the sensory block to pinprick has receded to a T10 level, the spinal is no longer as effective for surgical level pain relief. This is a measure of the duration of the spinal as an effective analgesic. Sensory recovery will be a T10 level. This will be measured in minutes.
Secondary Outcomes
- Patient Satisfaction Score(Post-Op Day 1)
- Time to Bromage Score 1(270 minutes)
- Blood Pressure(30 minutes)
- Phenylephrine Infusion Rate(2 to 30 minutes)
- Total Phenylephrine Infusion(during surgery which can go up to 150 minutes)
- Number of Phenylephrine Boluses(during surgery which can go up to 150 minutes)
- Number of Ephedrine Boluses(during surgery which can go up to 150 minutes)
- Number of Nausea episodes(60 minutes)
- Number of Vomiting episodes(60 minutes)
- Number of Shivering episodes(60 minutes)
- Number of Pruritus episodes(60 minutes)
- Pain Score at Skin Incision(within the surgery, which can go up to 150 minutes)
- Pain Score at Uterine Incision(within the surgery, which can go up to 150 minutes)
- Pain Score at Uterine Exteriorization(within the surgery, which can go up to 150 minutes)
- Pain Score at Uterine Closure(within the surgery, which can go up to 150 minutes)
- Pain Score at Gutter Cleaning(within the surgery, which can go up to 150 minutes)
- Pain Score at Procedure Finish(at procedure finish, which can go up to 150 minutes)
- Additional IV Medication(during surgery which can go up to 150 minutes)
- Number of participants who require Conversion to General Anesthesia(during surgery which can go up to 150 minutes)
- Heart Rate(total of 30 minutes from the time of spinal placement.)
- Oxygen Saturation(total of 30 minutes from the time of spinal placement.)
- Apgar Scores(1 minute and 5 minutes)
- Number of NICU admission(Day 1)
- Time to First opioid(24 hours)
- Total Opioid Dose(24 hours)
- Time to sensory block(20 minutes)
Investigators
Daniel Katz
Vice Chair of Education Department of Anesthesiology, Pain, & Perioperative Medicine
Icahn School of Medicine at Mount Sinai