Intrathecal Dexmedetomidine vs Epinephrine

Comparison of Intrathecal Epinephrine Versus Dexmedetomidine as Adjuvants in Cesarean Section

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 Overview

• Status: Recruiting
• Conditions: Cesarean Section; Anesthesia, Spinal
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Epinephrine; Drug: Standardized Spinal Mixture

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Talia Scott, MD; Phone Number: 720-212-7448; Email: talia.scott@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Hospital
      • Principal Investigator: Daniel Katz
      • Contact: Talia Scott, MD; Phone Number: 720-212-7448; Email: talia.scott@mountsinai.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexmedetomidine; receiving the addition of 5 mcg of dexmedetomidine to the standard spinal medication mixture.	Drug: Dexmedetomidine; 5 mcg of dexmedetomidine; Drug: Standardized Spinal Mixture; Standardized spinal mixture of 10.25 mg hyperbaric bupivacaine, and 0.125 mg morphine.
Active Comparator: Epinephrine; receiving the addition of 200 mcg of epinephrine to the standard spinal medication mixture	Drug: Epinephrine; 200 mcg of epinephrine; Drug: Standardized Spinal Mixture; Standardized spinal mixture of 10.25 mg hyperbaric bupivacaine, and 0.125 mg morphine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time required for sensory recovery	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.	270 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Bromage Score 1	Time to motor recovery determines how long the patient will be in the post anesthesia care unit. This will be measured in minutes. Bromage Scale to determine recovery where recovery will be Bromage 1. Bromage Scale: Bromage 0 full flexion knees and feet Bromage 1 just able to move knees Bromage 2 able to move feet only Bromage 3 unable to move feet or knees	270 minutes
Blood Pressure	Systolic and Diastolic Blood pressures will be measured preoperatively and then every 2 minutes for 10 minutes then every 5 minutes for a total of 30 minutes from the time of spinal placement.	30 minutes
Phenylephrine Infusion Rate	the phenylephrine infusion rate from 2 to 30 minutes after spinal placement	2 to 30 minutes
Total Phenylephrine Infusion	the total phenylephrine infusion given during surgery.	during surgery which can go up to 150 minutes
Number of Phenylephrine Boluses	Number of Phenylephrine Boluses given during the operation	during surgery which can go up to 150 minutes
Number of Ephedrine Boluses	Number of Ephedrine Boluses given during the operation	during surgery which can go up to 150 minutes
Number of Nausea episodes	Nausea will be assessed every 2 minutes for 10 minutes then every 5 minutes for a total of 30 minutes from the time of spinal placement. If patient self-reports or exhibits any of these symptoms after 30 minutes while still in OR, this will also be recorded until patient is in PACU.	60 minutes
Number of Vomiting episodes	Vomiting will be assessed every 2 minutes for 10 minutes then every 5 minutes for a total of 30 minutes from the time of spinal placement. If patient self-reports or exhibits any of these symptoms after 30 minutes while still in OR, this will also be recorded until patient is in PACU.	60 minutes
Number of Shivering episodes	Shivering will be assessed every 2 minutes for 10 minutes then every 5 minutes for a total of 30 minutes from the time of spinal placement. If patient self-reports or exhibits any of these symptoms after 30 minutes while still in OR, this will also be recorded until patient is in PACU.	60 minutes
Number of Pruritus episodes	Pruritus will be assessed every 2 minutes for 10 minutes then every 5 minutes for a total of 30 minutes from the time of spinal placement. If patient self-reports or exhibits any of these symptoms after 30 minutes while still in OR, this will also be recorded until patient is in PACU.	60 minutes
Pain Score at Skin Incision	Pain scores at time of skin incision. Pain will be graded on a scale of 0-10 (0 being no pain and 10 being the worst pain imaginable).	within the surgery, which can go up to 150 minutes
Pain Score at Uterine Incision	Pain scores at time of uterine incision. Pain will be graded on a scale of 0-10 (0 being no pain and 10 being the worst pain imaginable).	within the surgery, which can go up to 150 minutes
Pain Score at Uterine Exteriorization	Pain scores at time of uterine exteriorization. Pain will be graded on a scale of 0-10 (0 being no pain and 10 being the worst pain imaginable).	within the surgery, which can go up to 150 minutes
Pain Score at Uterine Closure	Pain scores at time of uterine closure. Pain will be graded on a scale of 0-10 (0 being no pain and 10 being the worst pain imaginable).	within the surgery, which can go up to 150 minutes
Pain Score at Gutter Cleaning	Pain scores at time of gutter cleaning. Pain will be graded on a scale of 0-10 (0 being no pain and 10 being the worst pain imaginable).	within the surgery, which can go up to 150 minutes
Pain Score at Procedure Finish	Pain scores at time of procedure finish . Pain will be graded on a scale of 0-10 (0 being no pain and 10 being the worst pain imaginable).	at procedure finish, which can go up to 150 minutes
Additional IV Medication	Any additional IV medications that need to be given during the surgery will be recorded (e.g. IV fentanyl).	during surgery which can go up to 150 minutes
Number of participants who require Conversion to General Anesthesia	Number of participants who require Conversion to General Anesthesia. If converted to general anesthesia, enrollment in study will end.	during surgery which can go up to 150 minutes
Heart Rate	Heart rate will be measured every 2 minutes for 10 minutes then every 5 minutes for a total of 30 minutes from the time of spinal placement.	total of 30 minutes from the time of spinal placement.
Oxygen Saturation	Oxygen saturation will be measured every 2 minutes for 10 minutes then every 5 minutes for a total of 30 minutes from the time of spinal placement.	total of 30 minutes from the time of spinal placement.
Apgar Scores	Neonatal Apgar Scores at 1 and 5 minutes will be recorded. Apgar score ranges from 0 to 10, with higher score indicating better health outcomes.	1 minute and 5 minutes
Number of NICU admission	Number of babies that require Neonatal Intensive Care Unit (NICU) admission from the OR.	Day 1
Patient Satisfaction Score	Patient will be asked to score satisfaction postoperatively Patient Satisfaction Score; Completely dissatisfied; Partially dissatisfied; Neutral; Partially satisfied; Completely satisfied	Post-Op Day 1
Time to First opioid	Via chart review, time to first opioid within a 24 hour time period after spinal placement.	24 hours
Total Opioid Dose	Via chart review, time to total opioids given within a 24 hour time period after spinal placement.	24 hours
Time to sensory block	Spinal Onset - The T4 sensory level is considered adequate for operative analgesia for cesarean delivery. Time to a sensory block to pinprick to T4 level over a 20 minute time period after spinal placement will be recorded. If T4 not reached, highest level achieved will be recorded. This will be measured in minutes.	20 minutes

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Daniel Katz, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: May 13, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Cesarean Section; Epinephrine; Spinal Anesthesia; Intrathecal adjuncts
• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Imidazoles; Amines; Catechols; Phenols; Benzene Derivatives; Alcohols; Amino Alcohols; Ethanolamines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Dexmedetomidine; Epinephrine
• Other Study ID Numbers: STUDY-23-01613

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan in place to share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No