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: Not yet recruiting
• Conditions: Cesarean Section; Anesthesia, Spinal
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Standardized Spinal Mixture; Drug: Epinephrine

• Study Type: Interventional
• Enrollment (Estimated): 90
• 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
      • 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; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pregnant patients aged 18-55 years who are presenting for scheduled cesarean section and are candidates for single shot spinal anesthesia for cesarean section.

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

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, 12.5 mcg fentanyl, and 0.125 mg morphine.
Active Comparator: Epinephrine; receiving the addition of 200 mcg of epinephrine to the standard spinal medication mixture	Drug: Standardized Spinal Mixture; Standardized spinal mixture of 10.25 mg hyperbaric bupivacaine, 12.5 mcg fentanyl, and 0.125 mg morphine.; Drug: Epinephrine; 200 mcg of epinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time required for sensory recovery at T10	Time required for sensory recovery at T10 to investigate the efficacy of adjuvant agents in cesarean section. Once the sensory block has receded to a T10 level, the spinal is no longer as effective for surgical level anesthesia. This will be measured in minutes.	360 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to motor and sensory recovery	Time to motor recovery determines how long the patient will be in the post anesthesia care unit.	480 minutes
Time to sensory recovery	The speed of sensory regression determines how long the spinal will be effective.	480 minutes
Time to administration of postoperative analgesic	The time to first postoperative analgesic gives information on how adequately pain is controlled postoperatively.	24 hours
Number of participants receiving intravenous opioid	The use of intravenous opioid agents such as fentanyl or morphine during the cesarean section can demonstrate that the spinal is not adequate for surgical anesthesia and analgesia. Any use of intravenous opioid administered during cesarean section is indicative of inadequate analgesia and the number of participants receiving this will be reported	360 minutes
Time required to achieve T4 anesthetic level	The onset time of the block can determine its feasibility in urgent situations where there is a time limit in which the surgeon must begin the operation.	60 minutes
Incidence of specific side effects	Incidence of intraoperative hypotension, nausea, vomiting, shivering, and pruritis. Unfavorable side effects should be assessed as they affect patient experience. These are potential side effects from the spinal anesthesia itself and the normal mixture of bupivacaine, morphine, and fentanyl.	360 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 (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

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): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Cesarean Section; Epinephrine; Spinal Anesthesia; Intrathecal adjuncts
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; 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